Drugs / Daratumumab
Daratumumab
also known as
DARZALEX · DARA · DARZALEX FASPRO · Dara SC · Daratumumab and Recombinant Human Hyaluronidase · JNJ-54767414 · 3003-005 · CT-P44 · +4 more
Monoclonal antibody targets CD38
Regulatory milestones approvals, filings & regulatory actions · 30 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed AH amyloidosis 1 milestone | |||||
| Filed | US (FDA) | DARZALEX FASPRO | AH amyloidosis | 2020-09-10 | “Janssen Submits Application Seeking U.S. FDA Approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Light Chain (AL) Amyloidosis” jnj.com ↗ |
| Filed plasma cell myeloma 8 milestones | |||||
| Filed | EU (EMA) | DARZALEX | plasma cell myeloma | 2024-10-10 | “Johnson & Johnson submits application to the European Medicines Agency for DARZALEX® (daratumumab) SC-based quadruplet regimen for newly diagnosed multiple myeloma patients” jnj.com ↗ |
| Filed | EU (EMA) | DARZALEX | plasma cell myeloma | 2024-03-04 | “submits application to the European Medicines Agency for DARZALEX® (daratumumab)-based quadruplet therapy” jnj.com ↗ |
| Filed | EU (EMA) | DARZALEX | plasma cell myeloma | 2019-07-19 | “today announced the submission of an extension application to the European Medicines Agency (EMA) for subcutaneous (under the skin) use of DARZALEX® (daratumumab)” jnj.com ↗ “has submitted an extension application to the European Medicines Agency (EMA) for the subcutaneous delivery of DARZALEX® (daratumumab)” halozyme.com ↗ |
| Filed | US (FDA) | DARZALEX | plasma cell myeloma | 2019-07-12 | “announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new subcutaneous (SC) formulation...” jnj.com ↗ “(Janssen) has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the subcutaneous delivery of DARZALEX® (daratumumab) for patients...” halozyme.com ↗ “Janssen Submits Application to U.S. FDA Seeking Approval of New DARZALEX® (daratumumab) Subcutaneous Formulation” jnj.com ↗ |
| Filed | EU (EMA) | DARZALEX | plasma cell myeloma | 2019-03-22 | “today announced the submission of a Type II variation application to the European Medicines Agency (EMA) for DARZALEX®▼ (daratumumab)” jnj.com ↗ “today announced the submission of a Type II variation application to the European Medicines Agency (EMA) for DARZALEX®▼ (daratumumab)” jnj.com ↗ “DARZALEX (daratumumab) - Janssen Submits Application to EMA for Novel Subcutaneous Formulation (EU)” jnj.com ↗ |
| Filed | US (FDA) | DARZALEX | plasma cell myeloma | 2019-03-12 | “Janssen Submits Application to U.S. FDA Seeking Approval of DARZALEX® (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible” jnj.com ↗ “Janssen Submits Application for DARZALEX® (daratumumab) Combination Therapy to U.S. FDA for Newly Diagnosed, Transplant Eligible Patients with Multiple Myeloma” jnj.com ↗ “submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX®(daratumumab)” jnj.com ↗ “In July, a rolling submission was completed with the FDA for the Biologic License Application for daratumumab for the treatment of multiple myeloma.” jnj.com ↗ “Regulatory applications for approval were submitted to the FDA and European Medicines Agency to expand the current indication of DARZALEX®” jnj.com ↗ |
| Filed | EU (EMA) | DARZALEX | plasma cell myeloma | 2017-11-21 | “announced the submission of a Type II variation application to the European Medicines Agency (EMA) , for the immunotherapy DARZALEX®▼ (daratumumab).” jnj.com ↗ “Regulatory applications for approval were submitted to the FDA and European Medicines Agency to expand the current indication of DARZALEX®” jnj.com ↗ |
| Filed | Other | — | plasma cell myeloma | — | “Health Canada has accepted for review the New Drug Submission (NDS) for daratumumab as a treatment for patients with multiple myeloma.” jnj.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 5 milestones | |||||
| Filed | US (FDA) | DARZALEX FASPRO | relapsed/refractory diffuse large B-cell lymphoma | 2026-06-13 | “The Company has submitted a supplemental Biologics License Application (sBLA) for the use of TALVEYand DARZALEX FASPRO” jnj.com ↗ |
| Filed | EU (EMA) | DARZALEX | relapsed/refractory diffuse large B-cell lymphoma | 2026-01-06 | “Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of TECVAYLI®▼(teclistamab) in combination with DARZALEX®...” jnj.com ↗ |
| Filed | US (FDA) | DARZALEX FASPRO | relapsed/refractory diffuse large B-cell lymphoma | 2020-11-12 | “Janssen submitted regulatory applications to the FDA and European Medicines Agency (EMA) seeking approval of DARZALEX FASPRO®” halozyme.com ↗ “Janssen Submits Applications in U.S. and EU Seeking Approval of DARZALEX FASPRO™” jnj.com ↗ “Janssen Submits Applications in U.S. and EU Seeking Approval of DARZALEX FASPRO” jnj.com ↗ |
| Filed | EU (EMA) | DARZALEX SC | relapsed/refractory diffuse large B-cell lymphoma | 2020-11-12 | “Janssen submitted regulatory applications to the FDA and European Medicines Agency (EMA) seeking approval of DARZALEX FASPRO®” halozyme.com ↗ “Janssen Submits Applications in U.S. and EU Seeking Approval of DARZALEX FASPRO™” jnj.com ↗ “Janssen Submits Applications in U.S. and EU Seeking Approval of DARZALEX FASPRO” jnj.com ↗ |
| Filed | US (FDA) | DARZALEX | relapsed/refractory diffuse large B-cell lymphoma | 2020-02-10 | “announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX®(daratumumab)” jnj.com ↗ “submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX®” jnj.com ↗ |
| Filed smoldering plasma cell myeloma 1 milestone | |||||
| Filed | US (FDA) | DARZALEX FASPRO | smoldering plasma cell myeloma | 2024-09-30 | “announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for DARZALEXFASPRO” jnj.com ↗ “The approval follows the regulatory submission to the FDA in November 2020 and marks the sixth indication for DARZALEX FASPRO®” jnj.com ↗ “In January 2024, Janssen announced submission of a sBLA to the FDA seeking approval of a new indication for DARZALEX FASPRO®” halozyme.com ↗ “An application for the approval of DARZALEXFASPRO®for adult patients with HR-SMM wassubmittedto the FDA in November 2024.” jnj.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (13) | US (FDA) | DARZALEX | — | 2016-11-21 – 2025-04-10 | fda.gov ↗ |
| Approved | EU (EMA) | Darzalex | — | 2016-05-20 | europa.eu ↗ |
| Approved | US (FDA) | DARZALEX | — | 2015-11-16 | fda.gov ↗ |
Trials 265 · started per year
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EU approved 2016
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT07026604 | Jul 2025 → Jul 2026 overdue | famililal cerebral cavernous malformations | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT04139304 | May 2021 → Jul 2029 expected | plasmablastic lymphoma | AIDS Malignancy Consortium | Recruiting | No outcome recorded |
| Phase 0 | NCT03473730 | May 2018 → Jan 2025 | clear cell renal carcinoma, urothelial carcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 137 trials | ||||||
| Phase 1 | NCT07341867 | Aug 2026 → Mar 2028 expected | plasma cell myeloma, triple-negative breast carcinoma | Andrew Hantel, MD | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07513129 | Jun 2026 → Dec 2029 expected | T-cell acute lymphoblastic leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05749276 | Feb 2025 → Aug 2028 expected | acute myeloid leukemia | Nantes University Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT06768489 | Dec 2024 → Jan 2029 expected | AL amyloidosis, smoldering plasma cell myeloma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT05832216 | Apr 2023 → Oct 2024 | aplastic anemia, blood platelet disease | Institute of Hematology & Blood Diseases Hospital, China | Completed | No outcome recorded |
| Phase 1 | NCT05641324 | Feb → Jul 2023 | plasma cell myeloma | Anaveon AG | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05556616 | Jan 2023 → Jun 2024 | plasma cell myeloma | Teva Branded Pharmaceutical Products R&D, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05137054 | Aug 2022 → Mar 2028 expected | plasma cell myeloma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT05004259 | Mar 2022 → Sep 2024 | hemolytic anemia | Dartmouth-Hitchcock Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT04895410 | Jan → Jun 2022 | plasma cell myeloma | AbbVie | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04667663 | Dec 2021 → Apr 2022 overdue | plasma cell myeloma | Cancer Trials Ireland | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05182073 | Nov 2021 → Sep 2024 | plasma cell myeloma | Fate Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT05050097 | Sep 2021 → Mar 2025 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04610320 | Jul 2021 → Jan 2024 | anti-HLA hyperimmunization, transplant rejection | Ronald Witteles | Completed | No outcome recorded |
| Phase 1 | NCT04892264 | Jun 2021 → Mar 2024 | plasma cell myeloma | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04088903 | Apr 2021 → Apr 2023 | anti-HLA hyperimmunization, transplant rejection | Ronald Witteles | Withdrawn | No outcome recorded |
| Phase 1 | NCT04614636 | Oct 2020 → Jul 2023 | acute myeloid leukemia, plasma cell myeloma | Fate Therapeutics | Terminated | No outcome recorded |
| Phase 1 | NCT04108195 | Feb 2020 → Apr 2027 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04121260 | Dec 2019 → Apr 2021 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04136756 | Oct 2019 → Apr 2023 | non-Hodgkin lymphoma, plasma cell myeloma | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04045028 | Jul 2019 → Mar 2023 | non-Hodgkin lymphoma, plasma cell myeloma | Genentech, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03447808 | Aug 2018 → May 2026 | B-cell chronic lymphocytic leukemia | Jennifer Woyach | Completed | No outcome recorded |
| Phase 1 | NCT03432741 | Mar 2018 → Aug 2022 | Hodgkins lymphoma, breast adenocarcinoma, mycosis fungoides, nodal marginal zone B-cell lymphoma | Mayo Clinic | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03311828 | Feb 2018 → Jan 2020 | AA amyloidosis, plasma cell myeloma | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT03283917 | Feb 2018 → Jun 2026 | AL amyloidosis | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03320707 | Oct 2017 → Aug 2019 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03242889 | Aug → Nov 2017 | plasma cell myeloma | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT03068351 | Jun 2017 → Aug 2019 | plasma cell myeloma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03177460 | Jun 2017 → Jan 2024 | prostate adenocarcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02955810 | Nov 2016 → Sep 2018 | plasma cell myeloma | National University of Ireland, Galway, Ireland | Unknown | No outcome recorded |
| Phase 1 | NCT02852837 | Sep 2016 → Dec 2019 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02918331 | Sep 2016 → Oct 2017 | plasma cell myeloma | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT02519452 | Oct 2015 → Dec 2017 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02431208 | Jul 2015 → Mar 2021 | plasma cell myeloma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02497378 | Jul 2015 → Mar 2018 | plasma cell myeloma | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT02116569 | Apr 2014 → Sep 2015 | plasma cell myeloma | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT01998971 | Feb 2014 → Jan 2019 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1/231 trials · 1 met primary · 1 missed | ||||||
| Phase 1/2 | NCT07681596 | Jul 2026 → Oct 2029 expected | refractory plasma cell neoplasm | AstraZeneca | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07287228 | Dec 2025 → Dec 2027 expected | aplastic anemia | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07110662 | Oct 2025 → Oct 2028 expected | severe cutaneous adverse reaction, toxic epidermal necrolysis | Hospices Civils de Lyon | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07075510 | Oct 2025 → Oct 2030 expected | plasma cell neoplasm | University of Maryland, Baltimore | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07099391 | Jul 2025 → Jul 2029 expected | plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06892522 | Jun 2025 → Feb 2036 expected | plasma cell myeloma | AbbVie | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06785415 | Mar 2025 → Apr 2031 expected | plasma cell myeloma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05486481 | Jan 2024 → Dec 2028 | AL amyloidosis | Alfred Chung, MD | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT06055075 | Dec 2023 → Jul 2025 | refractory plasma cell neoplasm | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1/2 | NCT06119685 | Oct 2023 → Dec 2025 overdue | non-Hodgkin lymphoma, plasma cell myeloma | Indapta Therapeutics, INC. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05671757 | May 2023 → Oct 2026 expected | autoimmune disease | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05857982 | May 2023 → Jan 2025 | refractory plasma cell neoplasm | Second Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| Phase 1/2 | NCT05434689 | Jan 2023 → Aug 2028 expected | plasma cell myeloma | University of Alabama at Birmingham | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04922723 | Oct 2022 → Dec 2026 expected | glioblastoma | West Virginia University | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05408026 | Oct 2022 → Oct 2025 | refractory plasma cell neoplasm | Alliance Foundation Trials, LLC. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT04827979 | Nov 2021 → Mar 2027 expected | anti-HLA hyperimmunization | National Institute of Allergy and Infectious Diseases (NIAID) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04973605 | Sep 2021 → Nov 2026 expected | refractory plasma cell neoplasm | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04204980 | Feb 2020 → Jun 2023 | anti-HLA hyperimmunization, transplant rejection | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 1/2 | NCT03537599 | Jan 2020 → Aug 2021 | acute myeloid leukemia with multilineage dysplasia, childhood acute myeloid leukemia | Sumithira Vasu | Terminated | No outcome recorded |
| Phase 1/2 | NCT03837509 | Sep 2019 → Apr 2022 | refractory plasma cell neoplasm | Incyte Corporation | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03732703 | Apr 2019 → Dec 2024 | refractory plasma cell neoplasm | Multiple Myeloma Research Consortium | Completed | No outcome recorded |
| Phase 1/2 | NCT03481556 | Apr 2018 → Feb 2022 | plasma cell myeloma | Oncopeptides AB | Terminated | No outcome recorded |
| Phase 1/2 | NCT03098550 | Jun 2017 → Jul 2020 | cancer of unknown primary site | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT02841033 | Mar 2017 → May 2020 | AL amyloidosis | Boston Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT03023423 | Dec 2016 → May 2018 | non-small cell lung carcinoma | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 1/2 | NCT02773030 | Oct 2016 → May 2024 overdue | plasma cell myeloma | Celgene Corporation | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02488759 | Oct 2015 → Mar 2021 | cancer of unknown primary site | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT02343042 | Oct 2015 → Apr 2027 expected | plasma cell myeloma | Karyopharm Therapeutics Inc | Recruiting | No outcome recorded |
| Phase 1/2 | NCT01665794 | Aug 2012 → Nov 2025 | plasma cell myeloma | University of Chicago | Completed | Met primary |
| Phase 1/2 | NCT01592370 | Aug 2012 → Sep 2020 | Hodgkins lymphoma, non-Hodgkin lymphoma, plasma cell myeloma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT01615029 | Jun 2012 → Oct 2015 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2145 trials · 3 met primary · 3 missed | ||||||
| Phase 2 | NCT07605416 | Apr 2027 → Nov 2032 expected | plasma cell leukemia | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07029776 | Mar 2027 → Apr 2030 expected | plasma cell myeloma | University of Arkansas | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07830485 | Oct 2026 → Apr 2029 expected | plasma cell myeloma | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07247097 | Aug 2026 → Dec 2030 expected | plasma cell myeloma | Massachusetts General Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06348147 | Jul 2026 → May 2027 | disease related to hematopoietic stem cell transplant, plasma cell myeloma | UNC Lineberger Comprehensive Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT07638683 | May 2026 → Jul 2028 expected | AL amyloidosis, plasma cell myeloma | Shanghai Zhongshan Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07485647 | May 2026 → May 2028 expected | plasma cell myeloma | Eden Biltibo | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07362238 | Mar 2026 → Mar 2028 expected | autoimmune thrombocytopenia | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT07362199 | Mar 2026 → Mar 2027 expected | autoimmune thrombocytopenia | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT07234019 | Jan 2026 → Nov 2028 expected | autoimmune thrombocytopenia | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Show all 145 trials opens the full record — a long page | ||||||
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT05403138 | Nov 2022 → Nov 2025 overdue | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Tianjin Medical University General Hospital | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT04513639 | Aug 2020 → Jun 2031 expected | plasma cell myeloma | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03357952 | Nov 2017 → Oct 2018 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2/3 | NCT02419118 | Jan → Oct 2015 | plasma cell myeloma | Vejle Hospital | Completed | No outcome recorded |
| Phase 330 trials · 19 met primary | ||||||
| Phase 3 | NCT07649525 | Jul 2026 → Jun 2033 expected | plasma cell leukemia, plasma cell myeloma | University of Leeds | Recruiting | No outcome recorded |
| Phase 3 | NCT07222761 | Jan 2026 → May 2029 expected | refractory plasma cell neoplasm | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06918002 | Jul 2025 → May 2036 expected | plasma cell myeloma | Intergroupe Francophone du Myelome | Recruiting | No outcome recorded |
| Phase 3 | NCT06867991 | Nov 2024 → Nov 2026 expected | anti-NMDA receptor encephalitis | The First People's Hospital of Changzhou | Recruiting | No outcome recorded |
| Phase 3 | NCT06187441 | May 2024 → Jan 2031 expected | plasma cell myeloma | HOVON Foundation | Recruiting | No outcome recorded |
| Phase 3 | NCT05438043 | Dec 2022 → Jan 2029 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05020236 | Oct 2021 → Apr 2026 overdue | plasma cell myeloma | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT04649060 | Dec 2020 → Feb 2022 | plasma cell myeloma, refractory plasma cell neoplasm | Oncopeptides AB | Terminated | Met primary Stop: Business |
| Phase 3 | NCT04181827 | Jun 2020 → May 2024 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT03993912 | Oct 2019 → Aug 2026 | plasma cell myeloma | University Hospital, Lille | Completed | Met primary |
| Phase 3 | NCT03937635 | Sep 2019 → Dec 2029 expected | smoldering plasma cell myeloma | ECOG-ACRIN Cancer Research Group | Recruiting | No outcome recorded |
| Phase 3 | NCT04071457 | Aug 2019 → Sep 2032 expected | plasma cell myeloma | SWOG Cancer Research Network | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03836014 | Jul 2019 → Jul 2026 overdue | plasma cell myeloma | Assistance Publique - Hôpitaux de Paris | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03901963 | Apr 2019 → Apr 2024 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT03651128 | Apr 2019 → Apr 2026 | plasma cell myeloma | Celgene Corporation | Completed | Met primary |
| Phase 3 | NCT03710603 | Dec 2018 → Aug 2023 overdue | plasma cell myeloma | Stichting European Myeloma Network | Active not recruiting | Met primary |
| Phase 3 | NCT03792620 | Nov 2018 → May 2020 | plasma cell myeloma | Grupo de Estudos Multicentricos em Onco-Hematologia | Unknown | No outcome recorded |
| Phase 3 | NCT03652064 | Nov 2018 → May 2024 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT03742297 | Oct 2018 → Jul 2023 overdue | plasma cell myeloma | PETHEMA Foundation | Active not recruiting | Met primary |
| Phase 3 | NCT03234972 | Nov 2017 → Oct 2019 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT03217812 | Nov 2017 → Jul 2020 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT03301220 | Nov 2017 → May 2024 | smoldering plasma cell myeloma | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT03277105 | Oct 2017 → Jun 2019 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT03201965 | Oct 2017 → Feb 2020 | amyloidosis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT03180736 | Jun 2017 → Jul 2020 | plasma cell myeloma | Stichting European Myeloma Network | Completed | Met primary |
| Phase 3 | NCT03158688 | Jun 2017 → Jul 2019 | plasma cell myeloma | Amgen | Completed | Met primary |
| Phase 3 | NCT02541383 | Sep 2015 → Aug 2020 | plasma cell myeloma | Intergroupe Francophone du Myelome | Completed | Met primary |
| Phase 3 | NCT02195479 | Dec 2014 → Nov 2017 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT02136134 | Aug 2014 → Jan 2016 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT02076009 | Jul 2014 → Mar 2016 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 47 trials | ||||||
| Phase 4 | NCT07191379 | Aug 2026 → Jun 2027 expected | plasma cell myeloma | Odense University Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07274462 | Nov 2025 → Mar 2027 expected | vasculitis | University Hospital, Martin | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06409702 | Jun 2024 → Nov 2027 expected | plasma cell myeloma | The First Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| Phase 4 | NCT05888870 | Nov 2023 → Dec 2026 expected | hemophilia A | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 4 | NCT05849740 | May 2023 → Apr 2027 expected | acquired hemophilia | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 4 | NCT05511428 | Nov 2022 → May 2024 | plasma cell myeloma | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 4 | NCT03829371 | Jan 2019 → Jan 2027 expected | plasma cell myeloma | University of Turin, Italy | Active not recruiting | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT06697483 | Dec 2024 → Dec 2026 expected | plasma cell myeloma | Peking University People's Hospital | Recruiting | No outcome recorded |
| — | NCT06455748 | Mar 2024 → Jan 2025 | AL amyloidosis | Yongyong MA | Unknown | No outcome recorded |
| — | NCT05913596 | May 2023 → Apr 2024 | transplant rejection | First Affiliated Hospital of Zhejiang University | Unknown | No outcome recorded |
| — | NCT06376214 | Jan 2023 → Dec 2025 overdue | AL amyloidosis | Nanjing University School of Medicine | Recruiting | No outcome recorded |
| — | NCT06571864 | Jan 2022 → Jan 2024 | AL amyloidosis | University of Turin, Italy | Completed | No outcome recorded |
| — | NCT05088330 | Dec 2021 → May 2023 | plasma cell myeloma | The First Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT04264884 | — | — | Janssen Research & Development, LLC | Approved for marketing | No outcome recorded |
| — | NCT02477891 | — | plasma cell myeloma | Janssen Research & Development, LLC | Approved for marketing | No outcome recorded |
| Comparator or background therapy84 trials | ||||||
| Phase 1 | NCT07221032 Background | Jul 2026 → Mar 2028 expected | plasma cell myeloma | Medical College of Wisconsin | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07082270 Background | Apr 2026 → Feb 2028 | plasma cell myeloma | Roswell Park Cancer Institute | Withdrawn | No outcome recorded |
| Phase 1 | NCT07400744 Comparator | Mar → Sep 2026 overdue | plasma cell myeloma | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06287944 Background | Jul 2025 → May 2028 expected | acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06622005 Background | Apr 2025 → Apr 2027 expected | plasma cell myeloma | Roswell Park Cancer Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT06042725 Background | Mar 2024 → Dec 2028 expected | plasma cell myeloma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 1 | NCT05974969 Comparator | May → Aug 2023 | — | Biocad | Completed | No outcome recorded |
| Phase 1 | NCT05679258 Comparator | Jan 2023 → Mar 2024 | plasma cell myeloma | Shanghai Henlius Biotech | Completed | Met primary |
| Phase 1 | NCT05363111 Background | Nov 2022 → Mar 2027 expected | plasma cell myeloma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05259839 Background | Oct 2022 → Sep 2033 expected | refractory plasma cell neoplasm | AbbVie | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05308654 Background | May 2022 → Feb 2024 overdue | refractory plasma cell neoplasm | AbbVie | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05243342 Background | Apr 2022 → Jul 2024 | plasma cell myeloma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04714372 Background | Nov 2021 → Jan 2024 | acute myeloid leukemia, monocytic leukemia | Masonic Cancer Center, University of Minnesota | Completed | No outcome recorded |
| Phase 1 | NCT04910568 Background | Jul 2021 → Dec 2028 expected | plasma cell myeloma | Genentech, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT04722146 Background | Mar 2021 → Oct 2025 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04280328 Background | Feb 2020 → Sep 2021 | plasma cell myeloma | Corvus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03591744 Background | Oct 2018 → Oct 2019 | plasma cell leukemia | City of Hope Medical Center | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT06953960 Background | Jul 2025 → Dec 2030 expected | plasma cell myeloma | AbbVie | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05590377 Background | Jan 2023 → May 2024 | plasma cell myeloma | Teva Branded Pharmaceutical Products R&D, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT05451771 Comparator | Oct 2022 → Sep 2027 expected | AL amyloidosis | Columbia University | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05581875 Background | Oct 2022 → Oct 2026 expected | corneal disorder, monoclonal paraproteinemia disease, plasma cell myeloma | Hellenic Society of Hematology | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05392946 Background | Aug 2022 → Sep 2026 overdue | plasma cell myeloma | Mayo Clinic | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05280275 Background | Apr 2022 → Mar 2026 | corneal disorder, monoclonal paraproteinemia disease, plasma cell myeloma | Hellenic Society of Hematology | Unknown | No outcome recorded |
| Phase 1/2 | NCT04942067 Background | Dec 2021 → Sep 2024 | amyloidosis, plasma cell myeloma | Ascentage Pharma Group Inc. | Unknown | No outcome recorded |
| Phase 1/2 | NCT05205252 Comparator | Dec 2021 → Jul 2023 | refractory hematologic cancer | Epizyme, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04824794 Comparator | Mar 2021 → Jun 2025 | acute myeloid leukemia, diffuse large B-cell lymphoma, refractory plasma cell neoplasm | Genmab | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03989414 Background | Sep 2019 → Nov 2026 expected | plasma cell myeloma | Celgene Corporation | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04068597 Background | Aug 2019 → Mar 2027 expected | T-cell non-Hodgkin lymphoma, acute myeloid leukemia, myelodysplastic syndrome, plasma cell myeloma | CellCentric Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03701321 Background | Jan 2019 → May 2020 | plasma cell myeloma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| Phase 2 | NCT06948084 Background | May 2027 → Feb 2028 expected | plasma cell myeloma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07149857 Background | Oct 2025 → Apr 2028 expected | plasma cell myeloma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT06974786 Background | Aug 2025 → Nov 2032 expected | plasma cell myeloma | SCRI Development Innovations, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT07045909 Background | Jun 2025 → Mar 2028 expected | plasma cell myeloma | PETHEMA Foundation | Recruiting | No outcome recorded |
| Phase 2 | NCT06931704 Comparator | May 2025 → Nov 2030 expected | plasma cell myeloma | Nantes University Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06577025 Background | Aug 2024 → Sep 2030 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06169215 Background | Jul 2024 → Apr 2026 overdue | plasma cell myeloma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06353022 Background | Jun 2024 → Apr 2028 expected | plasma cell myeloma | Nantes University Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05896228 Background | Feb 2024 → Mar 2029 expected | plasma cell myeloma | Benjamin T Diamond, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT06889948 Comparator | Jan 2024 → Jun 2027 expected | glomerulonephritis, kidney failure, monoclonal paraproteinemia disease | Helsinki University Central Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05231629 Background | Dec 2023 → Sep 2028 expected | plasma cell myeloma | University of Alabama at Birmingham | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04756401 Background | Dec 2022 → Aug 2025 overdue | plasma cell myeloma | Academic and Community Cancer Research United | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05695508 Background | Dec 2022 → Sep 2028 expected | plasma cell myeloma | University of Heidelberg Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04223661 Background | Dec 2021 → Dec 2022 | plasma cell myeloma | Attaya Suvannasankha | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04205240 Background | Dec 2020 → May 2021 | plasma cell myeloma | Srinivas Devarakonda | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04407442 Background | Nov 2020 → Apr 2023 | plasma cell myeloma | University of California, San Francisco | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04304144 Background | Mar 2020 → Nov 2023 | AL amyloidosis | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04133636 Background | Nov 2019 → Feb 2027 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03314181 Background | Apr 2018 → May 2031 expected | plasma cell myeloma | AbbVie | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03215524 Background | Oct 2017 → Jun 2022 | plasma cell myeloma | Canadian Myeloma Research Group | Completed | No outcome recorded |
| Phase 2/3 | NCT07428369 Comparator | Jun 2026 → May 2038 | plasma cell myeloma | Regeneron Pharmaceuticals | Withdrawn | No outcome recorded Stop: Business |
| Phase 2/3 | NCT07095452 Background | Jan 2026 → Sep 2040 expected | plasma cell myeloma | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT07709715 Comparator | Jan 2027 → Dec 2028 expected | AL amyloidosis | Nexcella Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07665450 Background | Sep 2026 → Sep 2030 expected | plasma cell myeloma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07285239 Comparator | Jul 2026 → Nov 2031 expected | plasma cell myeloma | PrECOG, LLC. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07671287 Background | Jun 2026 → Feb 2031 expected | plasma cell myeloma | University of Heidelberg Medical Center | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07555938 Comparator | Jun 2026 → Oct 2028 expected | plasma cell myeloma | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT07623798 Comparator | Jun 2026 → May 2029 expected | refractory plasma cell neoplasm | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07393282 Comparator | May 2026 → Jul 2033 expected | smoldering plasma cell myeloma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT07452198 Comparator | Mar 2026 → Mar 2029 expected | plasma cell myeloma | Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07391657 Comparator | Feb 2026 → Jun 2028 expected | refractory plasma cell neoplasm | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06932562 Background | Dec 2025 → Dec 2036 expected | plasma cell myeloma | European Myeloma Network B.V. | Recruiting | No outcome recorded |
| Phase 3 | NCT06952478 Comparator | Aug 2025 → Nov 2027 expected | refractory plasma cell neoplasm | Celltrion | Recruiting | No outcome recorded |
| Phase 3 | NCT06895512 Comparator | Apr 2025 → Jul 2027 expected | plasma cell myeloma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06615479 Background | Mar 2025 → Dec 2027 expected | refractory plasma cell neoplasm | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Recruiting | No outcome recorded |
| Phase 3 | NCT06679101 Comparator | Dec 2024 → Apr 2031 expected | plasma cell myeloma | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT06413498 Comparator | Aug 2024 → Jul 2028 expected | plasma cell myeloma | Kite, A Gilead Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06232707 Comparator | May 2024 → Nov 2025 | plasma cell myeloma | Celgene Corporation | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT06182774 Comparator | Apr 2024 → Jan 2032 expected | plasma cell myeloma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 3 | NCT06464991 Comparator | Mar 2024 → Aug 2027 expected | plasma cell myeloma | Nanjing IASO Biotechnology Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05257083 Background | Oct 2023 → Jun 2033 expected | plasma cell myeloma | Stichting European Myeloma Network | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05776940 Comparator | Mar 2023 → Mar 2026 | AL amyloidosis | Air Force Military Medical University, China | Unknown | No outcome recorded |
| Phase 3 | NCT05675319 Comparator | Mar 2023 → Mar 2025 | plasma cell myeloma | University Medical Center Hamburg-Eppendorf | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT05623020 Background | Nov 2022 → Oct 2030 expected | plasma cell myeloma | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT05552222 Background | Oct 2022 → Apr 2031 expected | plasma cell myeloma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT05455320 Background | Oct 2022 → Jul 2027 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT04975997 Comparator | Jun 2022 → Nov 2027 expected | plasma cell myeloma | Celgene Corporation | Active not recruiting | Met primary |
| Phase 3 | NCT05083169 Background | Oct 2021 → Aug 2025 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT06868667 Comparator | Jul 2021 → Apr 2024 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06868654 Comparator | Jul 2021 → Apr 2024 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | Met primary |
| Phase 3 | NCT04246047 Comparator | May 2020 → Oct 2023 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | Met primary |
| Phase 3 | NCT04288765 Background | Mar 2020 → Dec 2024 | plasma cell myeloma | Grupo Cooperativo de Hemopatías Malignas | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02252172 Comparator | Feb 2015 → Sep 2018 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| — | NCT07081126 Comparator | Jul 2025 → Jul 2026 overdue | acute transplant rejection | University Hospital, Martin | Recruiting | No outcome recorded |
| — | NCT06192979 Background | Jan 2024 → Sep 2026 overdue | primary systemic amyloidosis | Jin Lu, MD | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 207
| Date | Issuer | Release |
|---|---|---|
| 2026-10-08 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces ZENBEXUS (iberdomide) in Combination with Daratumumab and Dexamethasone (ZDd) Demonstrates Superior Progression-Free Survival vs. Standard of Care in Relapsed and Refractory Multiple Myeloma in Phase 3... bms.com ↗
Results showed ZDd demonstrated a statistically significant improvement in the dual-primary endpoint of progression-free survival (PFS) |
| 2026-09-25 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces First Presentation of Results for ZENBEXUS™ (iberdomide) in Combination with Daratumumab from Phase 3 EXCALIBER-RRMM Trial in Relapsed or Refractory Multiple Myeloma bms.com ↗
Results presented at IMS 2026 show ZENBEXUS in combination with daratumumab and dexamethasone doubled minimal residual disease-negative complete response rates versus daratumumab, bortezomib and dexamethasone (41.1% vs. 20.7%) |
| 2026-09-23 | Janssen Research & Development, LLC | Results New model-based analysis further supports the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to redefine long-term survival expectations in early line relapsed/refractory multiple myeloma jnj.com ↗
In the MajesTEC-3 study, TECVAYLI®plus DARZALEXFASPRO®significantly improved overall survival versus standard of care (SOC), with an estimated 83% of patients alive at 3 years. |
| 2026-09-23 | Janssen Research & Development, LLC | Results New model-based analysis further supports the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to redefine long-term survival expectations in early line relapsed/refractory multiple myeloma jnj.com ↗ |
| 2026-08-13 | Bristol-Myers Squibb | Regulatory U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse bms.com ↗ |
| 2026-06-26 | Janssen Research & Development, LLC | Regulatory CHMP recommendation advances Johnson & Johnson’s TECVAYLI®▼ (teclistamab) plus daratumumab as a potential standard of care for relapsed/refractory multiple myeloma jnj.com ↗
CHMP recommendation advances Johnson & Johnson’s TECVAYLI®▼ (teclistamab) plus daratumumab as a potential standard of care for relapsed/refractory multiple myeloma |
| 2026-06-13 | Janssen Research & Development, LLC | Results New TALVEY® (talquetamab-tgvs) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) data demonstrate the strength of a bispecific combination in earlier-line relapsed or refractory multiple myeloma jnj.com ↗
Results showed a progression-free survival (PFS) rate of up to 81.3% versus standard of care (51.2%) and an overall survival (OS) rate of up to 89.2% versus standard of care (79.1%) at 24 months. |
| 2026-06-13 | Janssen Research & Development, LLC | Results New TALVEY® (talquetamab-tgvs) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) data demonstrate the strength of a bispecific combination in earlier-line relapsed or refractory multiple myeloma jnj.com ↗
TALVEY plus DARZALEX FASPRO with or without pomalidomide showed progression-free survival of up to 81% and overall survival of up to 89% at 24 months |
| 2026-03-06 | Halozyme Therapeutics | Regulatory U.S. FDA Approves TECVAYLI® in Combination with DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma halozyme.com ↗
The newly approved TECVAYLI plus DARZALEX FASPRO treatment regimen, in which both drugs are administered subcutaneously, offers patients with relapsed or refractory multiple myeloma a new, effective treatment option that can be administered across all treatment settings. |
| 2026-03-05 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line jnj.com ↗ |
| 2026-01-27 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO®-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible jnj.com ↗ |
| 2026-01-27 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO®-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible jnj.com ↗
DARZALEX FASPRO®-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible |
| 2026-01-06 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits application to the European Medicines Agency for TECVAYLI®▼ (teclistamab) in combination with DARZALEX® (daratumumab) subcutaneous formulation for patients with relapsed/refractory multiple myeloma jnj.com ↗
Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of TECVAYLI®▼(teclistamab) in combination with DARZALEX®subcutaneous (daratumumab SC) formulation for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy. |
| 2026-01-06 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits application to the European Medicines Agency for TECVAYLI®▼ (teclistamab) in combination with DARZALEX® (daratumumab) subcutaneous formulation for patients with relapsed/refractory multiple myeloma jnj.com ↗
Johnson & Johnson submits application to the European Medicines Agency for TECVAYLI®▼ (teclistamab) in combination with DARZALEX® (daratumumab) subcutaneous formulation for patients with relapsed/refractory multiple myeloma |
| 2025-12-23 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - DARATUMUMAB INJECTION OBTAINS CLINICAL TRIAL APPROVAL IN CHINA irasia.com ↗
Daratumumab Injection (the ‘‘Product ’’) developed by the Group has obtained approval from the Natio nal Medical Products Administration of the People ’s Republic of China to conduct clinical trials in China. |
| 2025-12-09 | Janssen Research & Development, LLC | Results Unprecedented results from the Phase 3 MajesTEC-3 study support TECVAYLI® plus DARZALEX FASPRO® as a potential standard of care as early as second line for patients with relapsed/refractory multiple myeloma jnj.com ↗
Results show an 83% reduction in the risk of disease progression or death compared to standard regimens at nearly three-years follow-up (hazard ratio [HR], 0.17; 95 percent confidence interval [CI], 0.12-0.23; P<0.0001). |
| 2025-12-09 | Janssen Research & Development, LLC | Results Unprecedented results from the Phase 3 MajesTEC-3 study support TECVAYLI® plus DARZALEX FASPRO® as a potential standard of care as early as second line for patients with relapsed/refractory multiple myeloma jnj.com ↗ |
| 2025-12-01 | Bristol-Myers Squibb | Results Bristol Myers Squibb Data at ASH 2025 Showcase Potential of Hematology Pipeline and Build Momentum for Next Generation Portfolio bms.com ↗
Phase 1b/2a new data reinforce the potential of iberdomide + daratumumab + dexamethasone in transplant-deferred or ineligible NDMM, with strong efficacy, safety, PK outcomes and sustained minimal residual disease (MRD) negativity (Poster presentation #2255) |
| 2025-11-07 | Halozyme Therapeutics | Regulatory FDA Approved DARZALEX Faspro® for Adult Patients with High-Risk Smoldering Multiple Myeloma halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson received U.S. Food and Drug Administration (FDA) approval of a new indication for DARZALEX Faspro® (daratumumab and hyaluronidase-fihj) co-formulated with ENHANZE®, as single agent treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM). |
| 2025-11-06 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO® is the first and only treatment approved by the U.S. FDA for patients with high-risk smoldering multiple myeloma jnj.com ↗ |
| 2025-10-16 | Janssen Research & Development, LLC | Results TECVAYLI® plus DARZALEX FASPRO® combination regimen significantly improves progression-free survival and overall survival versus standard of care jnj.com ↗
MajesTEC-3 is the first Phase 3 study to show that the combination of TECVAYLI and DARZALEXFASPROoffers better PFS and OS than current standards of care. |
| 2025-10-16 | Janssen Research & Development, LLC | Results TECVAYLI® plus DARZALEX FASPRO® combination regimen significantly improves progression-free survival and overall survival versus standard of care jnj.com ↗ |
| 2025-09-23 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Phase 3 EXCALIBER-RRMM Study Evaluating Iberdomide in Combination with Standard Therapies Demonstrated a Significant Improvement in Minimal Residual Disease Negativity Rates in Relapsed or Refractory Multiple Myeloma bms.com ↗
The safety profile of iberdomide in combination with daratumumab and dexamethasone in this study is generally consistent with previous studies. |
| 2025-09-19 | Janssen Research & Development, LLC | Results TECVAYLI® and DARZALEX FASPRO® treatment demonstrates 100 percent overall response rate in transplant-eligible patients newly diagnosed with multiple myeloma jnj.com ↗
Patients receiving the immune-based combination as the first treatment after diagnosis achieved a 100 percent overall response rate. |
| 2025-09-19 | Janssen Research & Development, LLC | Results TECVAYLI® plus DARZALEX FASPRO® treatment demonstrates 100 percent overall response rate in transplant-eligible patients newly diagnosed with multiple myeloma jnj.com ↗
Patients receiving the immune-based combination as the first treatment after diagnosis achieved a 100 percent overall response rate. |
| 2025-07-23 | Janssen Research & Development, LLC | Regulatory European Commission approves DARZALEX® (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved a new indication for DARZALEX®(daratumumab) subcutaneous (SC) formulation as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma. |
| 2025-07-23 | Janssen Research & Development, LLC | Regulatory European Commission approves DARZALEX® (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma jnj.com ↗
European Commission approves DARZALEX® (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma |
| 2025-07-23 | Halozyme Therapeutics | Regulatory European Commission Approved DARZALEX Faspro® for Adult Patients with Smouldering Multiple Myeloma halozyme.com ↗ |
| 2025-06-20 | Janssen Research & Development, LLC | Regulatory DARZALEX® (daratumumab) receives the first positive CHMP opinion for patients with high-risk smouldering multiple myeloma jnj.com ↗
“The positive recommendation from the CHMP marks an important step towards addressing the needs of people living with high-risk smouldering multiple myeloma,” said Ester in’t Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine. |
| 2025-06-20 | Janssen Research & Development, LLC | Regulatory DARZALEX® (daratumumab) receives the first positive CHMP opinion for patients with high-risk smouldering multiple myeloma jnj.com ↗ |
| 2025-06-03 | Janssen Research & Development, LLC | Results DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimen shows 95 percent progression-free survival at four years in transplant-eligible, newly diagnosed patients with multiple myeloma who achieved sustained MRD negativity jnj.com ↗ |
| 2025-06-03 | Janssen Research & Development, LLC | Results DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimen shows 95 percent progression-free survival at four years in transplant-eligible, newly diagnosed patients with multiple myeloma who achieved sustained MRD negativity jnj.com ↗ |
| 2025-05-20 | Janssen Research & Development, LLC | Regulatory U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma jnj.com ↗ |
| 2025-04-25 | Allarity Therapeutics | Results Allarity Therapeutics Presents Novel Drug Response Predictor—DRP®—for Daratumumab in Multiple Myeloma at AACR 2025 allarity.com ↗
From this analysis, the Company identified a total of 53 genes—27 associated with sensitivity and 26 with resistance—which form the basis of this drug-specific DRP. |
| 2025-04-09 | Halozyme Therapeutics | Regulatory European Commission Approved Subcutaneous DARZALEX® (daratumumab)-based Quadruplet Regimen for the Treatment of Patients with Newly Diagnosed Multiple Myeloma, Regardless of Transplant Eligibility halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval for an indication extension of DARZALEX® (daratumumab) subcutaneous (SC) co-formulated with ENHANZE® in the frontline setting. |
| 2025-04-07 | Janssen Research & Development, LLC | Regulatory European Commission approves Johnson & Johnson’s subcutaneous DARZALEX® (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved an indication extension of DARZALEX®(daratumumab) subcutaneous (SC) formulation in the frontline setting. |
| 2025-04-07 | Janssen Research & Development, LLC | Regulatory European Commission approves Johnson & Johnson’s subcutaneous DARZALEX® (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved an indication extension of DARZALEX® (daratumumab) subcutaneous (SC) formulation in the frontline setting. |
| 2025-03-10 | Genmab | Results Genmab Announces Johnson & Johnson Decision Regarding HexaBody®-CD38 genmab.com ↗
Preliminary data submitted by Genmab to J&J, inclusive of 88 patients who received a study treatment and 84 patients who were response evaluable (42 in each arm), demonstrated an overall response rate (ORR) of 55% (95% CI: 39%, 70%) in the HexaBoby-CD38 IV arm vs. 52% in the daratumumab SC arm (95% CI: 36%, 68%); very |
| 2025-02-28 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson’s DARZALEX® (daratumumab) subcutaneous-based regimen receives positive CHMP opinion for patients with newly diagnosed multiple myeloma, regardless of transplant eligibility jnj.com ↗
The recommendation is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM). |
| 2025-02-28 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson’s DARZALEX® (daratumumab) subcutaneous-based regimen receives positive CHMP opinion for patients with newly diagnosed multiple myeloma, regardless of transplant eligibility jnj.com ↗
today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an indication extension of DARZALEX® (daratumumab) subcutaneous (SC) formulation in the frontline setting. |
| 2024-12-09 | GlaxoSmithKline | Results Blenrep shows significant overall survival benefit, reducing the risk of death by 42% in multiple myeloma at or after first relapse gsk.com ↗
DREAMM-7 trial shows sustained overall survival benefit for Blenrep (belantamab mafodotin) combination versus daratumumab combination; benefit seen early and maintained through follow-up |
| 2024-12-08 | Janssen Research & Development, LLC | Results TECVAYLI® (teclistamab-cqyv) demonstrates potential as frontline combination therapy for patients with newly diagnosed multiple myeloma jnj.com ↗
All patients who were evaluated for MRD negativity after cycle 3 of induction therapy achieved MRD negativity (10-5) and maintained through cycle 6.1 |
| 2024-12-08 | Janssen Research & Development, LLC | Results DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) shows 51 percent reduction in risk of progression to active multiple myeloma for patients with high-risk smoldering multiple myeloma jnj.com ↗ |
| 2024-12-08 | Janssen Research & Development, LLC | Results DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimens demonstrate improved rates of minimal residual disease (MRD) negativity and progression-free survival in patients with newly diagnosed multiple myeloma jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced data highlighting that DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj)-based regimens improve overall and sustained minimal residual disease (MRD) negativity rates and progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status. |
| 2024-12-08 | Janssen Research & Development, LLC | Results TECVAYLI® (teclistamab-cqyv) demonstrates potential as frontline combination therapy for patients with newly diagnosed multiple myeloma jnj.com ↗
All patients who were evaluated for MRD negativity after cycle 3 of induction therapy achieved MRD negativity (10) and maintained through cycle 6. |
| 2024-12-08 | Janssen Research & Development, LLC | Results DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimens demonstrate improved rates of minimal residual disease (MRD) negativity and progression-free survival in patients with newly diagnosed multiple myeloma jnj.com ↗ |
| 2024-11-19 | Bristol-Myers Squibb | Results Bristol Myers Squibb’s Presentations at ASH 2024 Reinforce Strength of Hematology Portfolio and Scientific Advances in Differentiated Research Platforms bms.com ↗
Updated results from Phase 1/2 CC-220-MM-001 trial supporting clinical and pharmacological activity of iberdomide combined with daratumumab and dexamethasone in transplant-ineligible, newly-diagnosed MM patients, including those with high-risk markers |
| 2024-11-08 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO® / DARZALEX® as subcutaneous monotherapy for high-risk smoldering multiple myeloma jnj.com ↗ |
| 2024-11-08 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO® / DARZALEX® as subcutaneous monotherapy for high-risk smoldering multiple myeloma jnj.com ↗ |
| 2024-10-23 | Janssen Research & Development, LLC | Regulatory DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible jnj.com ↗ |
| 2024-10-23 | Janssen Research & Development, LLC | Regulatory DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible jnj.com ↗
DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible |
| 2024-10-10 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits application to the European Medicines Agency for DARZALEX® (daratumumab) SC-based quadruplet regimen for newly diagnosed multiple myeloma patients jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of DARZALEX®(daratumumab) subcutaneous (SC) formulation in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM). |
| 2024-10-10 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits application to the European Medicines Agency for DARZALEX® (daratumumab) SC-based quadruplet regimen for newly diagnosed multiple myeloma patients jnj.com ↗
Johnson & Johnson submits application to the European Medicines Agency for DARZALEX® (daratumumab) SC-based quadruplet regimen for newly diagnosed multiple myeloma patients |
| 2024-10-02 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson files for U.S. FDA approval of DARZALEX FASPRO®-based quadruplet regimen for newly diagnosed multiple myeloma patients for whom transplant is not planned jnj.com ↗ |
| 2024-09-30 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson files for U.S. FDA approval of DARZALEX FASPRO®-based quadruplet regimen for newly diagnosed multiple myeloma patients for whom transplant is not planned jnj.com ↗ |
| 2024-09-27 | Janssen Research & Development, LLC | Results TALVEY® (talquetamab-tgvs) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) based combination shows deep and durable responses in patients with relapsed or refractory multiple myeloma jnj.com ↗
RIO DE JANEIRO (September 27, 2024)– Johnson & Johnson (NYSE: JNJ) today announced updated results from the investigational Phase 1b TRIMM-2 study evaluating the combination of TALVEY®(talquetamab-tgvs) with DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj) and pomalidomide in patients with relapsed or refractory multiple myeloma that demonstrated an overall response rate (ORR) of 82 percent, further supporting the investigation of this combination. |
| 2024-09-27 | Janssen Research & Development, LLC | Results DARZALEX FASPRO®-based quadruplet regimen significantly improves minimal residual disease negativity for newly diagnosed multiple myeloma patients for whom transplant is not planned jnj.com ↗
The proportion of patients achieving sustained MRD-negativity of ≥ 12 months almost doubled with D-VRd vs VRd (48.7 percent vs 26.3 percent;P<0.0001). |
| 2024-09-27 | Janssen Research & Development, LLC | Results DARZALEX® (daratumumab)-based maintenance regimens show clinically meaningful deep and durable responses in transplant-eligible patients with newly diagnosed multiple myeloma jnj.com ↗
DARZALEX®maintenance reduced the risk of progression or death by 24% in patients who received DARZALEX®and VTd as induction and consolidation. |
| 2024-09-27 | Janssen Research & Development, LLC | Results TALVEY® (talquetamab-tgvs) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) based combination shows deep and durable responses in patients with relapsed or refractory multiple myeloma jnj.com ↗ |
| 2024-09-27 | Janssen Research & Development, LLC | Results DARZALEX® (daratumumab)-based maintenance regimens show clinically meaningful deep and durable responses in transplant-eligible patients with newly diagnosed multiple myeloma jnj.com ↗ |
| 2024-09-27 | Janssen Research & Development, LLC | Results DARZALEX FASPRO®-based quadruplet regimen significantly improves minimal residual disease negativity for newly diagnosed multiple myeloma patients for whom transplant is not planned jnj.com ↗
Results show that treatment with D-VRd resulted in deeper responses, including MRD-negativity, compared with VRd. |
| 2024-09-20 | Janssen Research & Development, LLC | Regulatory DARZALEX® (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a Type II variation for DARZALEX®(daratumumab) subcutaneous (SC) formulation. |
| 2024-09-20 | Janssen Research & Development, LLC | Regulatory DARZALEX® (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a Type II variation for DARZALEX® (daratumumab) subcutaneous (SC) formulation. |
| 2024-07-30 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen approved in the U.S. for patients with newly diagnosed multiple myeloma who are transplant-eligible jnj.com ↗ |
| 2024-07-30 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen approved in the U.S. for patients with newly diagnosed multiple myeloma who are transplant-eligible jnj.com ↗ |
| 2024-06-03 | Janssen Research & Development, LLC | Results TECVAYLI® (teclistamab-cqyv) shows sustained deep and durable responses in patients with relapsed or refractory multiple myeloma jnj.com ↗
At a median follow-up of 13.8 months, the ORR was 92 percent, with 23 patients remaining on treatment. |
| 2024-06-03 | Janssen Research & Development, LLC | Results DARZALEX® (daratumumab)-based regimens significantly improve clinical outcomes in both transplant-eligible and -ineligible patients who are newly diagnosed with multiple myeloma jnj.com ↗ |
| 2024-06-03 | Janssen Research & Development, LLC | Results TECVAYLI® (teclistamab-cqyv) shows sustained deep and durable responses in patients with relapsed or refractory multiple myeloma jnj.com ↗
At a median follow-up of 13.8 months, the ORR was 92 percent, with 23 patients remaining on treatment. |
| 2024-06-03 | Janssen Research & Development, LLC | Results DARZALEX® (daratumumab)-based regimens significantly improve clinical outcomes in both transplant-eligible and -ineligible patients who are newly diagnosed with multiple myeloma jnj.com ↗
DARZALEX® (daratumumab)-based regimens significantly improve clinical outcomes in both transplant-eligible and -ineligible patients who are newly diagnosed with multiple myeloma |
| 2024-05-23 | Janssen Research & Development, LLC | Results Johnson & Johnson advances leadership in oncology innovation with more than 75 clinical study and real-world presentations at ASCO and EHA jnj.com ↗ |
| 2024-05-23 | Janssen Research & Development, LLC | Results Johnson & Johnson advances leadership in oncology innovation with more than 75 clinical study and real-world presentations at ASCO and EHA jnj.com ↗
Final overall survival analysis from the Phase 3 MAIA study evaluating DARZALEX® plus lenalidomide and dexamethasone compared to lenalidomide and dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma (Poster Abstract #P968) |
| 2024-05-23 | Bristol-Myers Squibb | Results Bristol Myers Squibb to Present Data at ASCO & EHA from More Than 130 Studies Across 25 Diseases Supporting Expansion into New Indications, Demonstrating Long-Term Survival, and Highlighting Novel Modalities and Research Platforms bms.com ↗
Iberdomide is immune stimulatory and induces deep anti-myeloma activity across doses in combination with daratumumab in patients with TNE NDMM from the CC-220-MM-001 study. |
| 2024-03-06 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits application to the European Medicines Agency for DARZALEX® (daratumumab)-based quadruplet therapy for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, today announced the submission of a Type II variation application to the European Medicines Agency (EMA). |
| 2024-03-04 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits application to the European Medicines Agency for DARZALEX® (daratumumab)-based quadruplet therapy for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma jnj.com ↗
BEERSE, BELGIUM (04 March 2024) – Janssen-Cilag International NV, a Johnson & Johnson company, today announced the submission of a Type II variation application to the European Medicines Agency (EMA). |
| 2024-02-05 | GlaxoSmithKline | Results DREAMM-7 phase III trial shows Blenrep combination nearly tripled median progression-free survival versus standard of care combination in patients with relapsed/refractory multiple myeloma gsk.com ↗
With a median follow-up of 28.2 months, the median PFS was 36.6 months (95% CI: 28.4-not reached [NR]) with the belantamab mafodotin combination compared to 13.4 months (11.1-17.5) in the daratumumab combination. |
| 2024-01-30 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits supplemental Biologics License Application to U.S. FDA seeking approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimen for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma jnj.com ↗
Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for DARZALEXFASPRO® |
| 2024-01-30 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits supplemental Biologics License Application to U.S. FDA seeking approval of DARZALEX FASPRO based regimen for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma jnj.com ↗ |
| 2023-12-12 | Janssen Research & Development, LLC | Results DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet therapy regimen shows significant improvement in outcomes for patients with transplant-eligible newly diagnosed multiple myeloma jnj.com ↗
The quadruplet regimen also significantly increased the depth of response compared to treatment with VRd alone, with higher rates of CR or better, stringent complete response (sCR), and MRD negativity. |
| 2023-12-12 | Janssen Research & Development, LLC | Results DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet therapy regimen shows significant improvement in outcomes for patients with transplant-eligible newly diagnosed multiple myeloma jnj.com ↗
DARZALEX FASPRO®-based induction, consolidation and maintenance regimen reduced risk of progression or death by 58 percent compared to standard of care regimen |
| 2023-12-11 | Janssen Research & Development, LLC | Results Treatment with CARVYKTI® (ciltacabtagene autoleucel) Resulted in Clinically Meaningful Improvements in Health-Related Quality of Life and Reductions in Disease-Specific Symptoms in Patients with Earlier-Line Multiple Myeloma jnj.com ↗ |
| 2023-12-11 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Data at ASH 2023 from Diverse Multiple Myeloma Pipeline, Underscoring Range of Tailored Treatment Approaches to Address Unique Patient Needs bms.com ↗
New results from the Phase 1 CC-92480-MM-002 study of oral CELMoD agent mezigdomide, including first results for cohorts evaluating mezigdomide and dexamethasone with monoclonal antibodies (anti-CD38 mAbs) daratumumab and elotuzumab |
| 2023-11-27 | GlaxoSmithKline | Results GSK announces positive results from DREAMM-7 head-to-head phase III trial for Blenrep in relapsed/refractory multiple myeloma gsk.com ↗
The trial met its primary endpoint of progression-free survival (PFS) and showed that belantamab mafodotin when combined with bortezomib plus dexamethasone (BorDex) significantly extended the time to disease progression or death versus daratumumab plus BorDex, an existing standard of care for relapsed/refractory multiple myeloma. |
| 2023-09-04 | Oncopeptides AB | Results Oncopeptides publishes two articles with results from ANCHOR and LIGHTHOUSE studies in Haematologica oncopeptides.com ↗
It concludes that melflufen plus daratumumab and dexamethasone demonstrated superior progression free survival (HR 0.18 [0.05-0.65], p=0.0032). |
| 2023-06-03 | Janssen Research & Development, LLC | Results Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
Additional long-term data from the TRiMM-2 study in patients receiving talquetamab and DARZALEX FASPRO® combination biweekly regimen showed an overall response rate of more than 80 percent |
| 2023-05-12 | Oncopeptides AB | Results Correction: Oncopeptides presents new data at the European Haematology Association meeting oncopeptides.com ↗ |
| 2023-05-11 | Oncopeptides AB | Results Oncopeptides presents new data at the European Haematology Association meeting oncopeptides.com ↗ |
| 2023-04-20 | Oncopeptides AB | Results Oncopeptides presents new scientific data at European Myeloma Network Meeting oncopeptides.com ↗
Data from the LIGHTHOUSE study is very encouraging and clearly indicates that the combination of melflufen plus daratumumab has a clinical benefit in patients with RRMM, |
| 2022-12-13 | Fate Therapeutics | Results Fate Therapeutics Features Multiple Novel Approaches to Eliminate Conditioning Chemotherapy for Off-the-shelf, iPSC-derived Cell Therapies at 2022 ASH Annual Meeting fatetherapeutics.com ↗
The translational findings suggest that following administration of daratumumab, CD38-null iNK cells may avoid rejection by activated host immune cells without requiring conditioning chemotherapy. |
| 2022-12-12 | Janssen Research & Development, LLC | Results Janssen Presents Efficacy and Subgroup Analyses from MAIA Study Showing Long-Term Results of DARZALEX® (daratumumab)-based Regimen in Newly Diagnosed, Transplant-Ineligible Multiple Myeloma jnj.com ↗
These updated findings continue to reinforce the overall survival benefit with the D-Rd regimen and provide important insights across key patient populations at varying ages and levels of cytogenetic risk. |
| 2022-12-12 | Janssen Research & Development, LLC | Results Janssen Presents Efficacy and Subgroup Analyses from MAIA Study Showing Long-Term Results of DARZALEX® (daratumumab)-based Regimen in Newly Diagnosed, TransplantIneligible Multiple Myeloma jnj.com ↗ |
| 2022-12-12 | Nektar Therapeutics | Results Nektar Announces Poster Presentations at the 64th American Society of Hematology (ASH) Annual Meeting nektar.com ↗ |
| 2022-12-10 | Janssen Research & Development, LLC | Results Janssen Presents First Data from MajesTEC-2 Trial of TECVAYLI™ (teclistamab-cqyv) in Combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and Lenalidomide in Relapsed or Refractory Multiple Myeloma jnj.com ↗
According to the results, the immune-based triplet therapy regimen had a manageable safety profile with no unexpected safety signals observed. |
| 2022-12-10 | Fate Therapeutics | Results Fate Therapeutics Highlights iPSC-derived, Off-the-shelf CAR NK Cell Programs for Multiple Myeloma at 2022 ASH Annual Meeting fatetherapeutics.com ↗
Interim Phase 1 Data of FT576 BCMA-targeted Product Candidate Show Clinical Activity in Initial Single-dose Escalation Cohorts as Monotherapy and in Combination with Daratumumab |
| 2022-11-03 | Artiva Biotherapeutics, Inc. | Results Artiva Announces Abstract Accepted for Presentation at the 64th American Society of Hematology Annual Meeting & Exposition artivabio.com ↗ |
| 2022-08-27 | Janssen Research & Development, LLC | Results Final Analysis of Phase 2 GRIFFIN Study Presented for DARZALEX® (daratumumab)-based Investigational Quadruplet Regimen in Patients with Newly Diagnosed, Transplant-Eligible Multiple Myeloma jnj.com ↗
Higher minimal residual disease (MRD) negativity rates were observed for DARZALEX®-RVd vs. RVd (64 percent vs. 30 percent). |
| 2022-08-27 | Janssen Research & Development, LLC | Results Final Analysis of Phase 2 GRIFFIN Study Presented for DARZALEX® (daratumumab)-based Investigational Quadruplet Regimen in Patients with Newly Diagnosed, Transplant-Eligible Multiple Myeloma jnj.com ↗
Data were presented in the plenary session at the 19th International Myeloma Society (IMS) Annual Meeting. |
| 2022-08-16 | Nektar Therapeutics | Results Nektar and Collaborators Announce Preclinical Publication of Data for NKTR-255 and its Observed Improvement of NK Cell Function in Multiple Myeloma nektar.com ↗
Furthermore, studies in a humanized MM mouse model show that NKTR-255 enhances in vitro antibody-dependent cellular cytotoxicity (ADCC) of NK cells and synergizes with daratumumab to reduce MM cell growth, |
| 2022-06-10 | Janssen Research & Development, LLC | Results Janssen Presents Updated Data at EHA for Teclistamab in Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
At a median follow-up of 8.6 months (range, 0.3-19.6), 76.5 percent (39/51) of response-evaluable patients enrolled in the study achieved a response, including 36 patients (70.6 percent) who achieved a very good partial response (VGPR) or better. |
| 2022-06-10 | Janssen Research & Development, LLC | Results Janssen Presents Updated Results Evaluating First-in-Class GPRC5D Bispecific Antibody Talquetamab in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
Updated results for talquetamab monotherapy and in combination with daratumumab highlighted in oral presentations at the 2022 EHA Annual Congress |
| 2022-06-05 | Janssen Research & Development, LLC | Results Updated Data for Janssen’s Bispecific Teclistamab Suggest Continued Deep and Durable Responses in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
Evaluable patients achieved an ORR of 76.5 percent at a median follow-up of 8.6 months (0.3–19.6). |
| 2021-12-13 | Janssen Research & Development, LLC | Results New Data from MajesTEC-1 Study Show Continued Deep and Durable Responses of Teclistamab (BCMAxCD3 Bispecific Antibody) in Treatment of Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
suggest a manageable safety profile and preliminary efficacy in patients with relapsed or refractory disease who had received a minimum of three prior lines of treatment. |
| 2021-12-11 | Janssen Research & Development, LLC | Results New Clinical and Real-World Data Support Use of DARZALEX® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma jnj.com ↗
The data show improved outcomes with the addition of DARZALEX®to bortezomib (VELCADE®), lenalidomide (Revlimid®) and dexamethasone (VRd), followed by DARZALEX®plus lenalidomide (R) maintenance therapy, in transplant-eligible patients. |
| 2021-12-11 | Janssen Research & Development, LLC | Results New Clinical and Real-World Data Support Use of DARZALEX® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma jnj.com ↗ |
| 2021-12-11 | Janssen Research & Development, LLC | Results Janssen Presents Updated Results Evaluating First-in-Class Talquetamab (GPRC5DxCD3 Bispecific Antibody) in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
Results suggest that the combination is tolerable in patients with relapsed or refractory multiple myeloma who had received a median of six prior lines of therapy (range 2-18) |
| 2021-12-01 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves DARZALEX FASPRO® (daratumumab and hyaluronidasefihj) in Combination with Carfilzomib and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse jnj.com ↗ |
| 2021-12-01 | Amgen | Regulatory FDA Approves New KYPROLIS® (carfilzomib) Combination Regimen With DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and dexamethasone For Patients With Multiple Myeloma At First Or Subsequent Relapse amgen.com ↗ |
| 2021-12-01 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Carfilzomib and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse halozyme.com ↗ |
| 2021-08-10 | Indapta Therapeutics, INC. | Results Indapta Therapeutics Announces New Preclinical Data Demonstrating Proprietary G-NK Cells Enhance Efficacy of Monoclonal Antibodies in Multiple Myeloma – Results published in Blood Advances – SAN FRANCISCO, indapta.com ↗
Results from in vitro assays showed G-NK cells had six-fold higher anti-myeloma cell-killing activity compared with conventional NK cells when combined with the mAb daratumumab or elotuzumab (p<0.001). |
| 2021-07-12 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse jnj.com ↗
The approval follows the regulatory submission to the FDA in November 2020 and marks the sixth indication for DARZALEX FASPRO® in the treatment of multiple myeloma. |
| 2021-07-12 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse halozyme.com ↗ |
| 2021-06-22 | Janssen Research & Development, LLC | Regulatory DARZALEX®▼ (daratumumab) Subcutaneous (SC) Formulation Becomes the First Approved Treatment for Newly Diagnosed Systemic Light Chain Amyloidosis in Europe and Gains an Additional Approval in Pre-Treated Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the European Commission (EC) has granted marketing authorisation for the expanded use of DARZALEX®▼ (daratumumab) subcutaneous (SC) formulation in two new indications. |
| 2021-06-22 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Receives European Marketing Authorizations for DARZALEX® (daratumumab) Subcutaneous Formulation for Newly Diagnosed Systemic Light-chain Amyloidosis and Pre-Treated Multiple Myeloma halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the European Commission (EC) has granted the Janssen Pharmaceutical Companies of Johnson & Johnson two marketing authorizations for the subcutaneous formulation of daratumumab, known as DARZALEX® SC in the European Union. |
| 2021-06-22 | Genmab | Regulatory Genmab Announces that Janssen has Received European Marketing Authorizations for DARZALEX® (daratumumab) Subcutaneous Formulation, Including for the Treatment of Patients with Newly Diagnosed Light-chain (AL) Amyloidosis genmab.com ↗
Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted marketing authorization for the daratumumab subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj), known as DARZALEX® SC in the European Union, in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adult patients with newly diagnosed systemic light-chain (AL) amyloidosis. |
| 2021-06-12 | Janssen Research & Development, LLC | Results Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible jnj.com ↗
The prespecified interim analysis for OS found that after a median follow-up of nearly five years (56.2 months), a 32 percent reduction in the risk of death was observed in the D-Rd treatment arm vs. Rd arm. |
| 2021-06-12 | Janssen Research & Development, LLC | Results Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible jnj.com ↗
The prespecified interim analysis for OS found that after a median follow-up of nearly five years (56.2 months), a 32 percent reduction in the risk of death was observed in the D-Rd treatment arm vs. Rd arm. |
| 2021-05-26 | Janssen Research & Development, LLC | Results Updated Data Demonstrate Significant Improvement in Hematologic Complete Response with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis jnj.com ↗
Longer-term results from a median follow-up of 20.3 months showed rates of hematologic complete response (hemCR) remained significantly higher in patients treated with DARZALEXFASPRO®in combination with bortezomib (VELCADE®), cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone (Abstract #8003). |
| 2021-05-26 | Janssen Research & Development, LLC | Results Updated Data Demonstrate Significant Improvement in Hematologic Complete Response with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis jnj.com ↗
Longer-term results from a median follow-up of 20.3 months showed rates of hematologic complete response (hemCR) remained significantly higher in patients treated with DARZALEX FASPRO® in combination with bortezomib (VELCADE®), cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone (Abstract #8003). |
| 2021-05-21 | Janssen Research & Development, LLC | Regulatory Janssen Receives Two Positive CHMP Opinions Recommending Expanded Use of DARZALEX®▼ (daratumumab) Subcutaneous (SC) Formulation for New Indications in Europe jnj.com ↗
One recommendation is for the use of daratumumab SC in combination with cyclophosphamide, bortezomib and dexamethasone (D-VCd), for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis. |
| 2021-05-21 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Receives Two Positive CHMP Opinions for DARZALEX® (daratumumab) Subcutaneous Formulation Utilizing ENHANZE® halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen Pharmaceutica N.V. (Janssen) received two positive opinions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending to broaden the existing marketing authorization for the DARZALEX® (daratumumab) subcutaneous (SC) formulation, which uses ENHANZE® technology, in two new indications. |
| 2021-05-21 | Genmab | Regulatory Genmab Announces that Janssen has Received Positive CHMP Opinion Recommending DARZALEX® (daratumumab) Subcutaneous (SC) Formulation for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis genmab.com ↗
Janssen received a positive CHMP opinion for DARZALEX® SC (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone for the treatment of adult patients with newly diagnosed systemic light-chain (AL) amyloidosis |
| 2021-05-19 | Oncopeptides AB | Results Oncopeptides AB: Oncopeptides presents clinical abstracts on melflufen at the 2021 American Society of Clinical Oncology oncopeptides.com ↗
The data presented here at ASCO data clearly support further development of melflufen in triplet regimens and reinforce the rational for the ongoing phase 3 LIGHTHOUSE study, comparing melflufen plus dexamethasone in combination with subcutaneous daratumumab with daratumumab alone. |
| 2021-04-19 | Janssen Research & Development, LLC | Regulatory DARZALEX® SC Becomes the First and Only Health Canada-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis, A Rare Disease jnj.com ↗
The DARZALEX® SC combination regimen is the first and only Health Canada approved treatment for patients with AL amyloidosis, 2 a rare blood cell disorder with no cure. |
| 2021-01-15 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis jnj.com ↗
This indication is approved under accelerated approval and is based on the hematologic complete response rate (hemCR) measure. |
| 2021-01-15 | Janssen Research & Development, LLC | Regulatory DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis jnj.com ↗
This indication is approved under accelerated approval and is based on the hematologic complete response rate (hemCR) measure. |
| 2021-01-15 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO® (Daratumumab And Hyaluronidase-fihj) As Treatment For Newly Diagnosed Patients With Light Chain (AL) Amyloidosis halozyme.com ↗
Janssen Biotech, Inc. (Janssen) has received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis. |
| 2021-01-15 | Genmab | Regulatory Genmab Announces that Janssen has been Granted U.S. FDA Approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis genmab.com ↗
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) approved by U.S. FDA as the first and only therapy for newly diagnosed Light-chain (AL) amyloidosis |
| 2020-12-07 | Janssen Research & Development, LLC | Results New DARZALEX® (daratumumab) Data from GRIFFIN Study Show Deeper and Longer Responses in Patients with Newly Diagnosed Multiple Myeloma jnj.com ↗
Phase 2 GRIFFIN data presented at ASH 2020 show increased stringent complete response and minimal residual disease negativity rates with maintenance therapy for transplant-eligible patients |
| 2020-12-07 | Janssen Research & Development, LLC | Results Data from the ANDROMEDA Study Show Hematologic Response for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Newly Diagnosed Light Chain (AL) Amyloidosis jnj.com ↗
Data from the ANDROMEDA Study Show Hematologic Response for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Newly Diagnosed Light Chain (AL) Amyloidosis |
| 2020-12-06 | Oncopeptides AB | Results Oncopeptides AB: Oncopeptides presents new data from phase 2 ANCHOR combination study in multiple myeloma at American Society of Hematology meeting ASH oncopeptides.com ↗
The overall response rate for melflufen plus dexamethasone was 73% in combination with daratumumab and 62% in combination with bortezomib. |
| 2020-12-04 | Janssen Research & Development, LLC | Results Data from the APOLLO Study Show Clinically Meaningful Response with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) Regimen After First or Subsequent Relapse in Multiple Myeloma jnj.com ↗
The APOLLO study represents the ninth positive Phase 3 study for daratumumab. |
| 2020-11-12 | Janssen Research & Development, LLC | Regulatory Janssen Submits Applications in U.S. and EU Seeking Approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj)/ DARZALEX® (daratumumab) Subcutaneous (SC) Formulation in Combination With Pomalidomide and Dexamethasone for Patients With Relapsed or Refractory Multiple Myeloma jnj.com ↗
The applications seek approval of the combination of DARZALEX FASPRO™/DARZALEX® SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. |
| 2020-11-12 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Submission Of Applications In US And EU Seeking Approval Of DARZALEX FASPRO™/ DARZALEX® Subcutaneous (SC) Formulation Utilizing ENHANZE® Technology, Combination With Pomalidomide And Dexamethasone For Patients With Relapsed Or Refractory Multiple Myeloma halozyme.com ↗
The applications seek approval of the combination of DARZALEX FASPRO™/ DARZALEX® SC with pomalidomide and dexamethasone (D-Pd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. |
| 2020-11-04 | Oncopeptides AB | Results Oncopeptides AB: Oncopeptides Announces that New Data for Melflufen is Accepted for Presentation at the Annual American Society of Hematology Meeting oncopeptides.com ↗
The updated analysis of the ongoing phase 1/2 ANCHOR study confirms the initial findings of encouraging activity as a triplet regimen with melflufen plus dexamethasone and either daratumumab or bortezomib |
| 2020-09-10 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application Seeking U.S. FDA Approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Light Chain (AL) Amyloidosis jnj.com ↗
Janssen Submits Application Seeking U.S. FDA Approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Light Chain (AL) Amyloidosis |
| 2020-09-10 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Submission For FDA Approval Of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) For The Treatment Of Patients With Light Chain (AL) Amyloidosis halozyme.com ↗ |
| 2020-08-24 | Ligand Pharmaceuticals | Regulatory Ligand Announces Amgen’s KYPROLIS® Approved by FDA as Combination Regimen with DARZALEX® and Dexamethasone in Once- and Twice-Weekly Dosing Regimens for Patients with Relapsed/Refractory Multiple Myeloma ligand.com ↗ |
| 2020-08-21 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves New DARZALEX® (daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma jnj.com ↗
U.S. FDA Approves New DARZALEX® (daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma |
| 2020-08-20 | Amgen | Regulatory FDA Approves New KYPROLIS® (carfilzomib) Combination Regimen With DARZALEX® (daratumumab) And Dexamethasone In Both Once- And Twice-Weekly Dosing Regimens amgen.com ↗ |
| 2020-06-15 | Janssen Research & Development, LLC | Results Subcutaneous Daratumumab Combination Resulted in Deep and Rapid Hematologic Responses and Improved Clinical Outcomes in the Treatment of Patients with Newly Diagnosed Light Chain (AL) Amyloidosis jnj.com ↗
The data demonstrated subcutaneous daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone (D-CyBorD) resulted in a higher hematologic complete response rate (CR), (53 percent vs. 18 percent [P<0.0001]), compared to CyBorD. |
| 2020-06-13 | Janssen Research & Development, LLC | Results Subcutaneous Daratumumab Combination Resulted in Deep and Rapid Hematologic Responses and Improved Clinical Outcomes in the Treatment of Patients with Newly Diagnosed Light Chain (AL) Amyloidosis jnj.com ↗ |
| 2020-06-04 | Janssen Research & Development, LLC | Regulatory European Commission Grants Marketing Authorisation for DARZALEX®▼(daratumumab) Subcutaneous Formulation for all Currently Approved Daratumumab Intravenous Formulation Indications jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted marketing authorisation for DARZALEX®▼ (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma (MM). |
| 2020-06-04 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Receives European Marketing Authorization For Subcutaneous DARZALEX® Utilizing Halozyme's ENHANZE® Technology For The Treatment Of Patients With Multiple Myeloma halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the European Commission (EC) has granted Janssen-Cilag International NV (Janssen) marketing authorization for the subcutaneous (SC) formulation of DARZALEX® (daratumumab), for the treatment of adult patients with multiple myeloma in all currently approved DARZALEX® intravenous (IV) formulation indications in frontline and relapsed / refractory settings. |
| 2020-05-01 | Janssen Research & Development, LLC | Regulatory U.S. Food and Drug Administration Approves DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the Treatment of Patients with Multiple Myeloma jnj.com ↗ |
| 2020-05-01 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO™ Utilizing Halozyme's ENHANZE® Technology For The Treatment Of Patients With Multiple Myeloma halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that its collaborator Janssen Biotech, Inc. (Janssen) has received approval from the U.S. Food and Drug Administration (FDA) for DARZALEX FASPRO™ (daratumumab hyaluronidase human- fihj). |
| 2020-04-30 | Janssen Research & Development, LLC | Regulatory CHMP Grants Positive Opinion for DARZALEX®▼(daratumumab) Subcutaneous Formulation for the Treatment of Patients with Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending approval for DARZALEX®▼ (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma in frontline and relapsed/refractory settings. |
| 2020-04-30 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen's Receipt Of CHMP Positive Opinion For DARZALEX® Subcutaneous Formulation Utilizing Halozyme's ENHANZE® Technology For Patients With Multiple Myeloma halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen-Cilag International NV (Janssen) received a Committee for Medicinal Products for Human Use (CHMP) Positive Opinion from the European Medicines Agency (EMA) recommending approval of a DARZALEX® (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma in frontline and relapsed/refractory settings. |
| 2020-02-10 | Janssen Research & Development, LLC | Regulatory Janssen Announces Submission to U.S. FDA for New DARZALEX® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma jnj.com ↗ |
| 2020-02-10 | Janssen Research & Development, LLC | Regulatory Janssen Announces Submission to U.S. FDA for New DARZALEX® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX® (daratumumab) in combination with Kyprolis® (carfilzomib) and dexamethasone (DKd) for relapsed/refractory multiple myeloma. |
| 2020-01-20 | Janssen Research & Development, LLC | Regulatory European Commission Approves Darzalex®▼ (daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone (VTd) for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) ha s granted marketing authorisation for Darzalex® (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). |
| 2019-12-10 | Janssen Research & Development, LLC | Results DARZALEX® (Daratumumab) Regimen Shows Significant Increase in Progression-Free Survival in Treatment of Patients with Relapsed/Refractory Multiple Myeloma jnj.com ↗
Results from the CANDOR study showed that, compared to Kd alone, DKd resulted in significantly longer PFS rates and response rates. |
| 2019-12-10 | Amgen | Results Amgen Data From Phase 3 CANDOR Study Combining KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab) To Be Presented During Late-Breaking Session At American Society Of Hematology Annual Meeting amgen.com ↗
Median PFS was not reached for the KdD arm versus 15.8 months for the Kd arm. |
| 2019-12-09 | Janssen Research & Development, LLC | Results DARZALEX® (Daratumumab) Shows Overall Survival Benefit and Continued Improvement in Progression-Free Survival in Patients with Newly Diagnosed Multiple Myeloma Who Are Ineligible for Transplant jnj.com ↗
These updated data from the ALCYONE study also demonstrated that the addition of DARZALEX®to VMP resulted in higher rates of minimal residual disease (MRD) negativity. |
| 2019-12-09 | Nektar Therapeutics | Results Nektar Therapeutics Announces Presentation of New Preclinical Data for its IL-15 Agonist, NKTR-255, at the American Society of Hematology (ASH) 2019 Annual Meeting nektar.com ↗
NKTR-255 was also able to revert the inhibitory status of NK cells from MM patients and showed synergy with daratumumab and elotuzumab to significantly increase status of NK susceptibility of the MM cells. |
| 2019-12-08 | Oncopeptides AB | Results Oncopeptides AB: Oncopeptides presents promising data from the Phase 2 ANCHOR combination study in patients with RRMM at ASH Annual Meeting 2019 oncopeptides.com ↗
In the data presented, melflufen and dexamethasone demonstrated positive efficacy in combination with daratumumab or bortezomib in patients with relapsed/refractory multiple myeloma (RRMM). |
| 2019-11-19 | Janssen Research & Development, LLC | Regulatory Janssen Receives EU Marketing Authorisation for Darzalex®▼(daratumumab) in Combination with Lenalidomide and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible jnj.com ↗
Janssen Receives EU Marketing Authorisation for Darzalex®▼(daratumumab) in Combination with Lenalidomide and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible |
| 2019-10-18 | Janssen Research & Development, LLC | Regulatory CHMP Grants Positive Opinion for Expanded Use of Janssen’s Darzalex®▼(daratumumab) for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible jnj.com ↗
CHMP Grants Positive Opinion for Expanded Use of Janssen’s Darzalex®▼(daratumumab) for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible |
| 2019-09-26 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma jnj.com ↗ |
| 2019-09-26 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma jnj.com ↗
Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma |
| 2019-09-15 | Janssen Research & Development, LLC | Results New DARZALEX® (daratumumab) Data from GRIFFIN Study Show High Response Rate and Depth of Response in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant-Eligible jnj.com ↗
New DARZALEX® (daratumumab) Data from GRIFFIN Study Show High Response Rate and Depth of Response in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant-Eligible |
| 2019-09-13 | Amgen | Results Amgen Announces Phase 3 CANDOR Study Combining KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab) Meets Primary Endpoint Of Progression-Free Survival amgen.com ↗
Amgen (NASDAQ:AMGN) today announced the Phase 3 CANDOR study evaluating KYPROLIS ® (carfilzomib) in combination with dexamethasone and DARZALEX ® (daratumumab) (KdD) compared to KYPROLIS and dexamethasone alone (Kd) met its primary endpoint of progression-free survival (PFS). |
| 2019-07-19 | Janssen Research & Development, LLC | Regulatory Janssen Seeks EMA Approval for Novel Subcutaneous Formulation of DARZALEX®▼ (daratumumab) jnj.com ↗ |
| 2019-07-19 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Submits Extension Application To European Medicines Agency For Subcutaneous Formulation Of DARZALEX® Utilizing ENHANZE® Technology halozyme.com ↗
Janssen-Cilag International NV (Janssen) has submitted an extension application to the European Medicines Agency (EMA) for the subcutaneous delivery of DARZALEX® (daratumumab) for patients with multiple myeloma. |
| 2019-07-12 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application to U.S. FDA Seeking Approval of New DARZALEX® (daratumumab) Subcutaneous Formulation jnj.com ↗ |
| 2019-07-12 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application to U.S. FDA Seeking Approval of New DARZALEX® (daratumumab) Subcutaneous Formulation jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new subcutaneous (SC) formulation of DARZALEX® (daratumumab), an intravenous (IV) treatment approved for certain patients with multiple myeloma. |
| 2019-07-12 | Halozyme Therapeutics | Regulatory Halozyme Announces Janssen Submits BLA To FDA For Subcutaneous Formulation Of DARZALEX® Utilizing ENHANZE® Technology halozyme.com ↗
"Janssen's BLA submission for subcutaneous DARZALEX® represents an important development for our ENHANZE® drug delivery technology business," said Dr. Helen Torley, president and chief executive officer. |
| 2019-06-27 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible jnj.com ↗ |
| 2019-06-27 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible jnj.com ↗
Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible |
| 2019-06-14 | Oncopeptides AB | Results Oncopeptides AB: New Data Presented at 24th EHA Congress from Oncopeptides’ Phase 1/2 ANCHOR Trial Evaluating Melflufen in Relapsed/Refractory Multiple Myeloma (RRMM) oncopeptides.com ↗
For patients that had completed two or more cycles of therapy the overall response rate (ORR) was 100% for the bortezomib combination and 82% for the daratumumab combination. |
| 2019-06-14 | Karyopharm Therapeutics Inc | Results Karyopharm Reports New and Updated Selinexor Combination Data from the Phase 1b/2 STOMP Study at the European Hematology Association 2019 Annual Meeting karyopharm.com ↗
Additionally, the Darzalex and Pomalyst arms of the STOMP study continue to demonstrate impressive response rates, including encouraging rates of very good partial responses (VGPR), which indicate a 90% or greater reduction in a patient’s disease burden. |
| 2019-06-03 | Janssen Research & Development, LLC | Results Phase 3 COLUMBA Study Investigating a Subcutaneous Formulation of DARZALEX® (daratumumab) Showed Non-Inferiority to Intravenous Administration in Patients with Relapsed/Refractory Multiple Myeloma jnj.com ↗
The results showed non-inferior efficacy and pharmacokinetics for the SC administered formulation of DARZALEX compared to intravenous (IV) administration, the only currently approved formulation of DARZALEX (abstract #8005). |
| 2019-06-03 | Janssen Research & Development, LLC | Results DARZALEX® (daratumumab) Investigational Study Shows Increased Depth of Response and Longer Progression-Free Survival in Patients with Newly Diagnosed Multiple Myeloma Who are Eligible for a Transplant jnj.com ↗ |
| 2019-06-02 | Janssen Research & Development, LLC | Results Phase 3 COLUMBA Study Investigating a Subcutaneous Formulation of DARZALEX® (daratumumab) Showed Non-Inferiority to Intravenous Administration in Patients with Relapsed/Refractory Multiple Myeloma jnj.com ↗
The results showed non-inferior efficacy and pharmacokinetics for the SC administered formulation of DARZALEX compared to intravenous (IV) administration, the only currently approved formulation of DARZALEX (abstract #8005). |
| 2019-06-02 | Janssen Research & Development, LLC | Results DARZALEX® (daratumumab) Investigational Study Shows Increased Depth of Response and Longer Progression-Free Survival in Patients with Newly Diagnosed Multiple Myeloma Who are Eligible for a Transplant jnj.com ↗
DARZALEX® (daratumumab) Investigational Study Shows Increased Depth of Response and Longer Progression-Free Survival in Patients with Newly Diagnosed Multiple Myeloma Who are Eligible for a Transplant |
| 2019-05-29 | Janssen Research & Development, LLC | Results DARZALEX® (daratumumab) Phase 3 MAIA Study Results Published in The New England Journal of Medicine Show Combination Therapy Increases Progression-Free Survival in Newly Diagnosed Patients with Multiple Myeloma Who are Transplant Ineligible jnj.com ↗
The median PFS for DARZALEX-Rd has not yet been reached, compared to 31.9 months for patients who received Rd alone. |
| 2019-04-08 | Actinium Pharmaceuticals | Results Actinium's Leading Clinical, Preclinical, Production and IP Efforts Related to Actinium-225 Highlighted at Preeminent Targeted Alpha Therapy International Symposium actiniumpharma.com ↗
The studies featured in the oral presentation observed enhanced potency, cell killing and tumor control with Ac-225 labeled daratumumab compared to naked daratumumab alone. |
| 2019-04-02 | Nektar Therapeutics | Results Nektar Therapeutics Presents Preclinical Data on its Immuno-Oncology Pipeline Candidates at the American Association for Cancer Research (AACR) Annual Meeting 2019 nektar.com ↗
NKTR-255 enhanced the therapeutic efficacy of antibodies, daratumumab or rituximab. |
| 2019-03-27 | Janssen Research & Development, LLC | Regulatory Janssen Seeks Expanded Use of DARZALEX®▼ (daratumumab) Combination Therapy for Newly Diagnosed, Transplant Eligible Patients with Multiple Myeloma jnj.com ↗
Janssen has also submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of daratumumab -VTd for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant (ASCT). |
| 2019-03-26 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application for DARZALEX® (daratumumab) Combination Therapy to U.S. FDA for Newly Diagnosed, Transplant Eligible Patients with Multiple Myeloma jnj.com ↗ |
| 2019-03-26 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application for DARZALEX® (daratumumab) Combination Therapy to U.S. FDA for Newly Diagnosed, Transplant Eligible Patients with Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX® (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant (ASCT). |
| 2019-03-22 | Janssen Research & Development, LLC | Regulatory Janssen Seeks Expanded Use of DARZALEX®▼ (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) for DARZALEX®▼ (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). |
| 2019-03-12 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application to U.S. FDA Seeking Approval of DARZALEX® (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible jnj.com ↗ |
| 2019-02-12 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves DARZALEX® (daratumumab) Split-Dosing Regimen jnj.com ↗
U.S. FDA Approves DARZALEX® (daratumumab) Split-Dosing Regimen |
| 2018-12-04 | Janssen Research & Development, LLC | Results New DARZALEX® (daratumumab) Phase 3 Study Shows Efficacy and Safety Data of AntiCD38 Monoclonal Antibody in Patients with Newly Diagnosed Multiple Myeloma jnj.com ↗
Phase 3 MAIA study results show DARZALEX in combination with lenalidomide and dexamethasone reduced the risk of disease progression or death in newly diagnosed patients who are transplant ineligible |
| 2018-12-04 | Fate Therapeutics | Results Fate Therapeutics Presents Off-the-Shelf CAR T and NK Cell Cancer Immunotherapy Pipeline at ASH Annual Meeting fatetherapeutics.com ↗
A poster presentation at ASH by scientists from the Company and the University of Minnesota highlighted new in vitro data showing that FT538 in combination with daratumumab is resistant to fratricide and eliminates multiple myeloma cancer cells in a serial re-challenge assay. |
| 2018-12-01 | Oncopeptides AB | Results Oncopeptides presents first interim data from the ongoing combination trial ANCHOR with melflufen at the 60th American Society of Hematology Meeting oncopeptides.com ↗
An Overall Response Rate (ORR) of 86% was observed with melflufen and dexamethasone in combination with daratumumab (CD38-directed monoclonal antibody) |
| 2018-08-08 | Janssen Research & Development, LLC | Regulatory Janssen Submits U.S. & EU Regulatory Applications Seeking Approval of DARZALEX® (daratumumab) Split Dosing Regimen jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA ) to the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of a split dosing regimen for DARZALEX® (daratumumab). |
| 2018-05-07 | Janssen Research & Development, LLC | Regulatory Janssen Announces DARZALEX® (daratumumab) U.S. FDA Approval for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible jnj.com ↗
Today’s FDA approval of DARZALEX® in combination with bortezomib, melphalan and prednisone marks its fifth indication in multiple myeloma |
| 2017-12-12 | Janssen Research & Development, LLC | Results DARZALEX® (daratumumab) Combination Regimen Significantly Improved Outcomes for Newly Diagnosed Multiple Myeloma Patients who are Transplant Ineligible jnj.com ↗
Phase 3 ALCYONE data showed DARZALEX in combination with bortezomib, melphalan and prednisone meaningfully improved progression-free survival and response rates |
| 2017-12-05 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Lifts Partial Clinical Holds on Two Opdivo-based Combination Studies in Multiple Myeloma bms.com ↗ |
| 2017-11-21 | Janssen Research & Development, LLC | Regulatory Janssen Seeks Expanded Use of DARZALEX®▼ (daratumumab) from EMA in Newly Diagnosed Multiple Myeloma jnj.com ↗
Janssen-Cilag International NV today announced the submission of a Type II variation application to the European Medicines Agency (EMA) , for the immunotherapy DARZALEX®▼ (daratumumab). |
| 2017-09-07 | AstraZeneca | Regulatory Celgene and AstraZeneca provide update on the FUSION clinical trial programme astrazeneca.com ↗
The FDA has taken similar action with other combination trials in patients with multiple myeloma. |
| 2017-09-06 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Provides an Update on Three Opdivo-based Combination Clinical Studies in Multiple Myeloma bms.com ↗
The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on CA209602 (CheckMate-602), CA209039 (CheckMate-039) and CA204142, three clinical trials investigating Opdivo (nivolumab)-based combinations in patients with relapsed or refractory multiple myeloma. |
| 2016-11-21 | Janssen Research & Development, LLC | Regulatory DARZALEX® (daratumumab) Approved by U.S. FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy jnj.com ↗
DARZALEX® (daratumumab) Approved by U.S. FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy |
| 2016-08-23 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application to the European Medicines Agency (EMA) to Expand Use of DARZALEX®▼ (daratumumab) to Include Combination with Standard of Care Regimens jnj.com ↗
Janssen Submits Application to the European Medicines Agency (EMA) to Expand Use of DARZALEX▼ (daratumumab) to Include Combination with Standard of Care Regimens |
| 2016-07-25 | Janssen Research & Development, LLC | Regulatory Daratumumab (DARZALEX®) Granted Breakthrough Therapy Designation by U.S. Food and Drug Administration (FDA) for Use in Combination with Standard of Care Regimens for Patients with Multiple Myeloma jnj.com ↗
Daratumumab (DARZALEX®) Granted Breakthrough Therapy Designation by U.S. Food and Drug Administration (FDA) for Use in Combination with Standard of Care Regimens for Patients with Multiple Myeloma |
| 2016-05-23 | Janssen Research & Development, LLC | Regulatory Janssen's Single-Agent DARZALEX® (daratumumab) Approved by European Commission for Treatment of Multiple Myeloma (MM) jnj.com ↗
Janssen-Cilag International NV ("Janssen") today announced that the European Commission (EC) has granted conditional approval to DARZALEX (daratumumab) for monotherapy of adult patients with relapsed and refractory multiple myeloma (MM), whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. |
| 2016-04-01 | Janssen Research & Development, LLC | Regulatory CHMP Issues a Positive Opinion on Janssen's Single-Agent DARZALEX® (daratumumab) jnj.com ↗ |
| 2016-03-30 | Janssen Research & Development, LLC | Results First Phase 3 Trial of Daratumumab in Combination with Standard Therapy in Relapsed/Refractory Multiple Myeloma Meets Primary Endpoint in Planned Interim Analysis jnj.com ↗
The interim analysis, conducted by an Independent Data Monitoring Committee (IDMC), found that the daratumumab combination treatment regimen improved progression-free survival (PFS) compared with bortezomib and dexamethasone alone, achieving the primary study endpoint (p < 0.0001). |
| 2015-11-18 | Janssen Research & Development, LLC | Regulatory Janssen's New Drug Submission for Daratumumab for Treatment of Multiple Myeloma Accepted for Review by Health Canada jnj.com ↗
Janssen Inc. announced today that Health Canada has accepted for review the New Drug Submission (NDS) for daratumumab as a treatment for patients with multiple myeloma. |
| 2015-11-16 | Janssen Research & Development, LLC | Regulatory DARZALEX® (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma jnj.com ↗ |
| 2015-09-25 | Janssen Research & Development, LLC | Regulatory Janssen's daratumumab accepted for accelerated CHMP assessment for treatment of European patients with heavily pre-treated multiple myeloma jnj.com ↗
Janssen-Cilag International NV announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has accepted its request for an accelerated assessment of the daratumumab Marketing Authorisation Application (MAA). |
| 2015-09-09 | Janssen Research & Development, LLC | Regulatory Janssen Submits Marketing Authorisation Application for daratumumab for European Patients With Heavily Pre-treated Multiple Myeloma jnj.com ↗
Janssen-Cilag International NV announced today it has submitted a new Marketing Authorisation Application to the European Medicines Agency (EMA) for daratumumab, an investigational, human anti-CD38 monoclonal antibody, for the treatment of patients with relapsed and refractory multiple myeloma. |
| 2015-09-04 | Janssen Research & Development, LLC | Regulatory U.S. FDA Grants Priority Review to Janssen for Daratumumab as a Treatment for Multiple Myeloma jnj.com ↗
With today's announcement, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of March 9, 2016 to render a decision on the daratumumab application. |
| 2015-06-05 | Janssen Research & Development, LLC | Regulatory Janssen Initiates Rolling Submission of Biologic License Application (BLA) for daratumumab with U.S. FDA for the Treatment of Multiple Myeloma jnj.com ↗
Janssen Initiates Rolling Submission of Biologic License Application (BLA) for daratumumab with U.S. FDA for the Treatment of Multiple Myeloma |
| 2015-05-30 | Janssen Research & Development, LLC | Results Data Show Daratumumab Achieved a Pronounced Overall Response Rate as a Single-Agent with Tolerable Safety Profile in Heavily Pre-Treated Multiple Myeloma Patients jnj.com ↗
Median duration of response was 7.4 months (95% CI, 5.5-not estimable). |
| 2015-05-20 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Pharmaceutical Segment to Continue Driving Above-Industry Growth with Plans to File More than 10 New Products by 2019, Each with Potential to Exceed $1 Billion in Revenue jnj.com ↗
Janssen is also announcing today that it plans to submit a Biologic Licensing Application to the FDA and a Marketing Authorization Application to the EMA this year for daratumumab in double refractory multiple myeloma. |
| 2013-05-01 | Janssen Research & Development, LLC | Regulatory Daratumumab Receives Breakthrough Therapy Designation in Double Refractory Multiple Myeloma from U.S. Food and Drug Administration jnj.com ↗
Janssen Research & Development, LLC (Janssen) announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and IMiD. |
All press releases naming this drug 254 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 254 releases opens the full record — a long page | ||
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 355 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | daratumumab | “APG-2575+ Lenalidomide administered at a dose of 25 mg orally (PO) on Days 1 through 21 of each 28-day cycle, dexamethasone will be administered at a dose of 40 mg (or 20 mg...” NCT04942067 ↗342“The purpose of this study is to find out whether Tec-RVd (teclistamab, lenalidomide, bortezomib, and dexamethasone) after 3 treatment Cycles of Dara-RVd (daratumumab,...” NCT07099391 ↗ “The purpose of this study is to evaluate the efficacy and safety of NXC-201 compared with Dara-CyBorD (daratumumab-cyclophosphamide-bortezomib-dexamethasone) in the treatment...” NCT07709715 ↗ “Induction therapy consist of bortezomib, lenalidomide, and dexamethasone (VRd) or daratumumab, lenalidomide, and dexamethasone (DRd) or daratumumab, bortezomib, lenalidomide,...” NCT07149857 ↗ “Anti-CD38 Monoclonal Antibody: Daratumumab is intravenously given at the dose of 16 mg/kg weekly for 8 weeks, then every two weeks for 8 more times, and lastly monthly until...” NCT06571864 ↗ “Daratumumab, IV, at 16 mg/kg, or Daratumumab, SC, at 1800 mg on days 1, 8, 15 and 22 for Cycles 1 and 2, on Days 1 and 15 for Cycles 3-6, and Day 1 of each cycle for Cycle 7...” NCT03215524 ↗ “Daratumumab and Dexamethasone Combined With Pomalidomide (DPD) or ASCT in the Treatment of Newly Diagnosed Systemic Light Chain Amyloidosis (AL Amyloidosis): a Prospective,...” NCT06376214 ↗ “induction therapy using the combination of dexamethasone, lenalidomide (revlimid), daratumumab (Darzalex) and carfilzomib (Kyprolis) to treat patients with newly diagnosed...” NCT03224507 ↗ “Daratumumab, a human IgG monoclonal antibody targeting CD38 with a direct on-tumor and immunomodulatory mechanism of action, has been approved to treat patients with multiple...” PMID 37022569 ↗ Apr 2023 “Phase II Clinical Study of Daratumumab Combined With Bortezomib, Lenalidomide and Dexamethasone (DVRd) in the Treatment of Patients With Newly Diagnosed Double-hit Multiple Myeloma” NCT06158269 ↗ “The therapeutic monoclonal antibody (t-mAb) daratumumab, used to treat multiple myeloma (MM) patients, interferes with routine, electrophoretic based M-protein diagnostics.” PMID 34392637 ↗ Aug 2021 |
| Known as | 3003-005 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743007 ↗ |
| Known as | CT-P44 | “Biological: CT-P44(Daratumumab)” NCT06952478 ↗ |
| Known as | DARA | “This phase 1b study (NCT02431208) evaluated the safety and efficacy of the anti-programmed death-ligand 1 monoclonal antibody atezolizumab (Atezo) alone or in combination with...” PMID 37559718 ↗ Jul 20234“This trial investigates the use of Daratumumab (DARA), an antibody directed at the human cluster of differentiation 38 (CD38) molecule, for the treatment of patients with...” NCT04396496 ↗ “Daratumumab (DARA) has shown impressive activity in combination with other agents for the treatment of multiple myeloma (MM).” PMID 31201169 ↗ Jun 2019 “Daratumumab (DARA) in combination with pomalidomide (POM) and low-dose dexamethasone (dex) (DPd)” NCT03651128 ↗ “Daratumumab (Dara)” NCT03829371 ↗ |
| Known as | Dara IV | “Participants will receive daratumumab for intravenous infusion (Dara IV) 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks on Day 1 in Cycle 7...” NCT03277105 ↗ |
| Known as | Dara SC | “Participants will receive a fixed dose of daratumumab as 1800 milligram (mg) subcutaneously (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per...” NCT03277105 ↗1“daratumumab subcutaneous (Dara-SC)” NCT03871829 ↗ |
| Known as | Daratumumab and Recombinant Human Hyaluronidase | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06169215 ↗ |
| Known as | Daratumumab component of darzalex faspro | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743007 ↗ |
| Known as | Daratumumab-fihj | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743007 ↗ |
| Known as | DARZALEX | “Daratumumab has been approved by the U.S. Food and Drug Administration (FDA) alone or in combination with other standard of care drugs for treatment of multiple myeloma in both...” NCT07075510 ↗11“DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma” NCT06895512 ↗ “KRdD = Kyprolis (Carfilzomib), Revlimid (Lenalidomide), dexamethasone, Darzalex (Daratumumab)” NCT03224507 ↗ “after receiving Darzalex (daratumumab) and then have a prostatectomy” NCT03035357 ↗ “has been approved since 2016 under the trade name Darzalex®” NCT04810754 ↗ “Daratumumab SC (Darzalex)” NCT06918002 ↗ “DARATUMUMAB (DARZALEX®)” NCT07274462 ↗ “DARATUMUMAB (DARZALEX®)” NCT07110662 ↗ |
| Known as | DARZALEX FASPRO | “Daratumumab has been approved by the U.S. Food and Drug Administration (FDA) alone or in combination with other standard of care drugs for treatment of multiple myeloma in both...” NCT07075510 ↗2“Dratumumab / Hyaluronidase Injection [Darzalex Faspro]” NCT06376214 ↗ “Biological: Darzalex Faspro(Daratumumab)” NCT06952478 ↗ |
| Known as | HUMAX-CD 38 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743007 ↗ |
| Known as | JNJ-54767414 | “JNJ-54767414 (Daratumumab) will be administered as an Intravenous (IV) infusion at a dose of 16 milligram per kilogram (mg/kg) weekly for the first 3 cycles, on Day 1 of Cycles...” NCT02497378 ↗1“A Study of JNJ-54767414 (Daratumumab) in Combination With Lenalidomide and Dexamethasone in Japanese Participants With Previously Untreated Multiple Myeloma Who Are Ineligible...” NCT02918331 ↗ |
| Action | Deplete | “elimination of CD38+ T cells” PMID 32928795 ↗ Sep 2020 |
| Modality | Monoclonal antibody | “Daratumumab is a CD38-targeted human monoclonal antibody” PMID 30536810 ↗ Dec 2018 |
| Route | Intravenous | “patients were given intravenous daratumumab 16 mg/kg” PMID 32470437 ↗ Jun 2020 |
| Target | CD38 | “Daratumumab is a CD38-targeted human monoclonal antibody” PMID 30536810 ↗ Dec 2018 |