Drugs / Teclistamab
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed plasma cell myeloma 2 milestones | |||||
| Filed | EU (EMA) | — | plasma cell myeloma | — | “a marketing authorization application (MAA) was submitted to the EMA for teclistamab approval in January 2022.” jnj.com ↗ “the MAA was submitted to the EMA for teclistamab approval in January 2022.” jnj.com ↗ |
| Filed | US (FDA) | — | plasma cell myeloma | — | “In December 2021, Janssen Research & Development, LLC submitted a Biologics License Application (BLA) to the FDA seeking approval of teclistamab” jnj.com ↗ “In December 2021, Janssen submitted a Biologics License Application (BLA) to the FDA seeking approval of teclistamab” jnj.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 4 milestones | |||||
| Filed | EU (EMA) | TECVAYLI | relapsed/refractory diffuse large B-cell lymphoma | 2026-03-10 | “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)...” jnj.com ↗ |
| Filed | US (FDA) | TECVAYLI | relapsed/refractory diffuse large B-cell lymphoma | 2026-01-06 | “has submitted a supplemental Biologics License Application (sBLA) for the use of teclistamab and daratumumab SC in combination as a treatment for RRMM” jnj.com ↗ |
| Filed | EU (EMA) | TECVAYLI | relapsed/refractory diffuse large B-cell lymphoma | 2026-01-06 | “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)” jnj.com ↗ |
| Filed | US (FDA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2021-12-29 | “The BLA submission for teclistama b is supported by data from MajesTEC-1” jnj.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved · conditional | EU (EMA) | Tecvayli | — | 2022-08-23 | europa.eu ↗ |
Trials 54
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07706205 | Sep 2026 → Dec 2027 expected | blood group incompatibility | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 19 trials | ||||||
| Phase 1 | NCT07332507 | Mar → Dec 2027 expected | plasmablastic lymphoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT07581704 | Jun 2026 → Jun 2029 expected | plasma cell myeloma | Christopher Strouse | Recruiting | No outcome recorded |
| Phase 1 | NCT07105059 | Aug 2025 → Aug 2028 expected | plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06465316 | Dec 2024 → Dec 2026 expected | plasma cell myeloma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT06425991 | Jun 2024 → Jun 2025 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05338775 | May 2022 → May 2025 overdue | refractory plasma cell neoplasm | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04722146 | Mar 2021 → Oct 2025 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | 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 | NCT03145181 | May 2017 → Sep 2025 overdue | hematopoietic and lymphoid cell neoplasm | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT07463807 | Jul → Aug 2026 overdue | plasma cell myeloma | National Cancer Institute (NCI) | Not yet 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 | NCT04696809 | Feb 2021 → Apr 2026 | hematopoietic and lymphoid cell neoplasm | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1/2 | NCT04586426 | Dec 2020 → Mar 2025 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 226 trials | ||||||
| Phase 2 | NCT06948084 | May 2027 → Feb 2028 expected | plasma cell myeloma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| 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 | NCT07791498 | Feb → Sep 2027 expected | Waldenstrom macroglobulinemia | Massachusetts General Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07631208 | Oct 2026 → Jan 2027 expected | interstitial lung disease | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | 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 | NCT07107529 | Dec 2025 → Apr 2029 expected | plasma cell myeloma | European Myeloma Network B.V. | Recruiting | No outcome recorded |
| Phase 2 | NCT07110844 | Nov 2025 → Oct 2031 expected | AL amyloidosis | Rajshekhar Chakraborty, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT06880601 | Nov 2025 → Nov 2029 expected | plasma cell myeloma | GIMEMA Foundation | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06993675 | Aug 2025 → Aug 2029 expected | plasma cell myeloma | Noffar Bar | Recruiting | No outcome recorded |
| Phase 2 | NCT06649695 | Jul 2025 → Sep 2028 expected | AL amyloidosis | European Myeloma Network B.V. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07079423 | Jun 2025 → Jan 2027 expected | AL amyloidosis | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06935162 | May 2025 → Dec 2026 expected | AL amyloidosis | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06758375 | Mar 2025 → Sep 2026 overdue | plasma cell myeloma | Hospital Universitario Dr. Jose E. Gonzalez | Recruiting | No outcome recorded |
| Phase 2 | NCT06171685 | Nov 2024 → Jul 2029 expected | plasma cell myeloma | Multiple Myeloma Research Consortium | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06577025 | Aug 2024 → Sep 2030 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06353022 | Jun 2024 → Apr 2028 expected | plasma cell myeloma | Nantes University Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06505369 | Jun 2024 → Nov 2026 expected | plasma cell myeloma | North Estonia Medical Centre | Recruiting | No outcome recorded |
| Phase 2 | NCT05572229 | Dec 2023 → Jun 2027 expected | plasma cell myeloma | University Hospital, Lille | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05231629 | Dec 2023 → Sep 2028 expected | plasma cell myeloma | University of Alabama at Birmingham | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06100237 | Dec 2023 → Dec 2028 expected | plasma cell myeloma | Carl Ola Landgren, MD, PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT05972135 | Oct 2023 → Aug 2027 expected | plasma cell myeloma | SCRI Development Innovations, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT05849610 | Sep 2023 → Mar 2026 overdue | — | PETHEMA Foundation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05695508 | Dec 2022 → Sep 2028 expected | plasma cell myeloma | University of Heidelberg Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05469893 | Aug 2022 → Jul 2030 expected | smoldering plasma cell myeloma | Irene Ghobrial, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT04557098 | Sep 2020 → Nov 2021 overdue | hematopoietic and lymphoid cell neoplasm | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 37 trials · 2 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 | NCT07671287 | Jun 2026 → Feb 2031 expected | plasma cell myeloma | University of Heidelberg Medical Center | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06208150 | Jan 2024 → Apr 2026 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05572515 | Mar 2023 → Oct 2025 overdue | refractory plasma cell neoplasm | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT05552222 | Oct 2022 → Apr 2031 expected | plasma cell myeloma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT05243797 | Sep 2022 → Apr 2028 expected | plasma cell myeloma | European Myeloma Network B.V. | Recruiting | No outcome recorded |
| Phase 3 | NCT05083169 | Oct 2021 → Aug 2025 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT07474961 | Mar 2027 → Dec 2036 expected | Waldenstrom macroglobulinemia, plasma cell myeloma | Anne Louise Tølbøll Sørensen | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07689149 | Jun 2026 → Dec 2029 expected | anti-HLA hyperimmunization, disease related to solid organ transplantation | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07030517 | May 2025 → Nov 2026 expected | plasma cell myeloma | Johnson & Johnson Private Limited | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06251076 | Nov 2024 → Jun 2026 overdue | plasma cell myeloma, refractory malignant neoplasm | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06699394 | Mar → Dec 2025 overdue | AL amyloidosis | Peking University People's Hospital | Recruiting | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT05161598 | — | plasma cell myeloma | Janssen Research & Development, LLC | No longer available | No outcome recorded |
| — | NCT05463939 | — | refractory plasma cell neoplasm | Janssen Research & Development, LLC | Approved for marketing | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT06588660 Background | Dec 2024 → Feb 2025 | plasma cell myeloma | University of Washington | Terminated | No outcome recorded Stop: Business |
| 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 2 | NCT07657312 Background | Jul 2026 → Dec 2027 expected | cytokine release syndrome, plasma cell myeloma | Naresh Bumma | Recruiting | No outcome recorded |
| Phase 2 | NCT06352866 Background | Jan → Apr 2025 | cytokine release syndrome, plasma cell myeloma | Jack Khouri, MD | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT07518186 Comparator | May 2026 → Apr 2029 expected | plasma cell myeloma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07258511 Comparator | Feb 2026 → Dec 2028 expected | plasma cell myeloma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 61
| Date | Issuer | Release |
|---|---|---|
| 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 ↗ |
| 2026-09-09 | Janssen Research & Development, LLC | Results Johnson & Johnson presents new data at IMS 2026 highlighting its industry-leading multiple myeloma portfolio, with the goal of advancing the potential for cure jnj.com ↗
with mixture cure modeling (MCM) estimating >85% statistical cure fractions and suggesting the potential to redefine long-term survival expectations for a substantial proportion of patients |
| 2026-07-23 | Janssen Research & Development, LLC | Results TECVAYLI® + TALVEY® reduced the risk of disease progression or death by 89% and the risk of death by 62% in earlier-line relapsed/refractory multiple myeloma jnj.com ↗
The study demonstrated statistically significant and clinically meaningful improvements in progression-free survival and overall survival for both investigational arms compared with investigator’s choice standard of care. |
| 2026-07-23 | Janssen Research & Development, LLC | Results TECVAYLI® + TALVEY® reduced the risk of disease progression or death by 89% and the risk of death by 62% in earlier-line relapsed/refractory multiple myeloma jnj.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 |
| 2026-05-29 | Janssen Research & Development, LLC | Results New TECVAYLI® data demonstrates superior progression-free and overall survival as early as first relapse in multiple myeloma jnj.com ↗
In a patient population whose myeloma was predominantly refractory to anti-CD38 therapy and lenalidomide, TECVAYLI®reduced the risk of disease progression or death by 71% and the risk of death by 40%. |
| 2026-05-29 | Janssen Research & Development, LLC | Results New TECVAYLI® (teclistamab-cqyv) data demonstrate superior progression-free and overall survival as early as first relapse in multiple myeloma jnj.com ↗
In a patient population whose myeloma was predominantly refractory to anti-CD38 therapy and lenalidomide, TECVAYLI reduced the risk of disease progression or death by 71% and the risk of death by 40%. |
| 2026-04-29 | Janssen Research & Development, LLC | Results Johnson & Johnson ushers in the next wave of innovation in cancer care with more than 20 clinical and real-world studies at ASCO 2026 jnj.com ↗
Results from MajesTEC-9, the second positive Phase 3 study of TECVAYLI® (teclistamab-cqyv), reinforce TECVAYLI® regimens as potential new standard of care in multiple myeloma as early as second line |
| 2026-03-10 | Janssen Research & Development, LLC | Regulatory TECVAYLI®▼ (teclistamab) monotherapy application submitted to the EMA for relapsed/refractory multiple myeloma after at least one prior therapy 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) as monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy. |
| 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 ↗ |
| 2026-03-05 | 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 ↗ |
| 2026-01-14 | Janssen Research & Development, LLC | Results TECVAYLI® monotherapy demonstrates superior progression-free and overall survival versus standard of care as early as first relapse in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide jnj.com ↗
Data confirm superior progression-free survival (PFS) and overall survival (OS) with TECVAYLI®compared to standard of care as early as second line.1 |
| 2026-01-14 | Janssen Research & Development, LLC | Results TECVAYLI® monotherapy demonstrates superior progression-free and overall survival versus standard of care as early as first relapse in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide jnj.com ↗ |
| 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 |
| 2025-12-15 | Janssen Research & Development, LLC | Regulatory TECVAYLI® plus DARZALEX FASPRO® combination selected for Commissioner’s National Priority Voucher Pilot program jnj.com ↗ |
| 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 ↗ |
| 2025-10-16 | 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 ↗ |
| 2025-09-19 | 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. |
| 2025-06-15 | Janssen Research & Development, LLC | Results Investigational combination of first-in-class bispecifics TALVEY® and TECVAYLI® shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease jnj.com ↗
The results show a high overall response rate (ORR) with durability in patients withtriple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM) who have true extramedullary disease (EMD). |
| 2025-06-15 | Janssen Research & Development, LLC | Results Investigational combination of first-in-class bispecifics TALVEY® and TECVAYLI® shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease jnj.com ↗
The results show a high overall response rate (ORR) with durability in patients with triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM) who have true extramedullary disease (EMD). |
| 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 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. |
| 2024-09-27 | Janssen Research & Development, LLC | Results Novel combination of TALVEY® (talquetamab-tgvs) and TECVAYLI® (teclistamab-cqyv) suggests high response rates and durable responses in triple-class refractory patients with relapsed or refractory multiple myeloma, including those with extramedullary disease jnj.com ↗
These results reflect promising efficacy and a manageable safety profile for this combination of two first-in-class, innovative bispecific therapies and provide a potentially promising off-the-shelf option for patients with advanced multiple myeloma. |
| 2024-09-27 | Janssen Research & Development, LLC | Results Novel combination of TALVEY® (talquetamab-tgvs) and TECVAYLI® (teclistamab-cqyv) suggests high response rates and durable responses in triple-class refractory patients with relapsed or refractory multiple myeloma, including those with extramedullary disease 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 ↗ |
| 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 ↗
TECVAYLI® (teclistamab-cqyv) shows sustained deep and durable responses in patients with relapsed or refractory multiple myeloma |
| 2024-02-20 | Janssen Research & Development, LLC | Regulatory TECVAYLI® (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma jnj.com ↗
There is a continued unmet need for patients with multiple myeloma and this approval allows increased flexibility in dosing schedule for appropriate patients with a weight-based regimen. |
| 2024-02-20 | Janssen Research & Development, LLC | Regulatory TECVAYLI® (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma jnj.com ↗
TECVAYLI® (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma |
| 2023-08-18 | Janssen Research & Development, LLC | Regulatory European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab) jnj.com ↗ |
| 2023-08-18 | Janssen Research & Development, LLC | Regulatory European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab) jnj.com ↗
European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab) |
| 2023-07-21 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinions for Novel Bispecific Antibodies TALVEY®▼ (talquetamab) and TECVAYLI®▼ (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma jnj.com ↗
The CHMP also recommended the approval of a Type II variation for teclistamab, providing a reduced, biweekly dosing schedule of 1.5mg/kg every other week in patients who have achieved a complete response or better for six months or longer. |
| 2023-06-05 | Janssen Research & Development, LLC | Results Janssen Presents Longer-Term Data for TECVAYLI® (teclistamab-cqyv) Showing a Duration of Response of 22 Months in Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
These results showed that nearly half of patients achieved a complete response (CR) or better which underscore the continued durable responses seen in this patient population. |
| 2023-06-05 | Janssen Research & Development, LLC | Results Janssen Presents Longer-Term Data for TECVAYLI® (teclistamab-cqyv) Showing a Duration of Response of 22 Months in Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗ |
| 2023-06-03 | Janssen Research & Development, LLC | Results Janssen Presents First-Ever Results from Dual Bispecific Combination Study Showing 96 Percent Overall Response Rate in Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
The investigational combination immunotherapy regimen demonstrated an ORR of 86.6 percent (71/82) across all dose levels, and an ORR of 96.3 percent (26/27) among patients receiving the recommended Phase 2 regimen (RP2R). |
| 2023-06-03 | Janssen Research & Development, LLC | Results Janssen Presents First-Ever Results from Dual Bispecific Combination Study Showing 96 Percent Overall Response Rate in Patients with Relapsed or Refractory Multiple Myeloma jnj.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. |
| 2022-10-25 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves TECVAYLI™ (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
This indication is approved under accelerated approval based on response rate. |
| 2022-10-25 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves TECVAYLI™ (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
This indication is approved under accelerated approval based on response rate. |
| 2022-08-24 | Janssen Research & Development, LLC | Regulatory Janssen Marks First Approval Worldwide for TECVAYLI® (teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma jnj.com ↗
Today’s milestone marks the first approval worldwide for teclistamab, a first-in-class bispecific antibody that redirects CD3-positive T-cells to B-cell maturation antigen (BCMA)-expressing myeloma cells to induce the killing of tumour cells. |
| 2022-08-24 | Janssen Research & Development, LLC | Regulatory Janssen Marks First Approval Worldwide for TECVAYLI®▼(teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted conditional marketing authorisation (CMA) of TECVAYLI®▼ (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). |
| 2022-07-22 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for Novel Bispecific Antibody TECVAYLI® (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma (RRMM) jnj.com ↗ |
| 2022-07-22 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for Novel Bispecific Antibody TECVAYLI® (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma (RRMM) jnj.com ↗
Teclistamab is the first T-cell redirecting bispecific antibody to receive a positive CHMP opinion for adults with RRMM and highlights Janssen’s commitment to innovation in multiple myeloma |
| 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. |
| 2022-06-05 | 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 ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated efficacy and safety results from the teclistamab Phase 1/2 MajesTEC-1 study. |
| 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 ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated efficacy and safety results from the teclistamab Phase 1/2 MajesTEC-1 study. |
| 2021-12-29 | Janssen Research & Development, LLC | Regulatory Janssen Submits Biologics License Application to U.S. FDA Seeking Approval of Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
Janssen Submits Biologics License Application to U.S. FDA Seeking Approval of Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma |
| 2021-12-22 | Janssen Research & Development, LLC | Regulatory Janssen Submits Biologics License Application to U.S. FDA Seeking Approval of Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma 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 teclistamab for the treatment of patients with relapsed or refractory (R/R) multiple myeloma. |
| 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 ↗
At the median follow-up of nearly eight months, an ORR of 62 percent (93/150; 95 percent Confidence Interval [CI], range, 53.7–69.8) was observed; ORR was consistent regardless of cytogenetic risk or extent of prior therapy refractoriness. |
| 2021-06-01 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for teclistamab in the treatment of relapsed or refractory multiple myeloma. |
| 2021-06-01 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for teclistamab in the treatment of relapsed or refractory multiple myeloma. |
| 2021-05-24 | Janssen Research & Development, LLC | Results Janssen’s Updated Phase 1 Results for Teclistamab Suggest Deep, Durable Responses in Patients with Heavily Pretreated Multiple Myeloma jnj.com ↗
After a median follow-up of 7.1 months (range, 3.0–12.2 months), median duration of response was not reached and 85 percent (22/26) of responders were alive and continuing treatment. |
| 2021-05-24 | Janssen Research & Development, LLC | Results Janssen Presents Updated Data on First-in-Class Talquetamab at ASCO Suggesting Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
both bispecific therapies induced changes in levels of sBCMA that correlated with clinical activity. |
| 2021-05-24 | Janssen Research & Development, LLC | Results Janssen’s Updated Phase 1 Results for Teclistamab Suggest Deep, Durable Responses in Patients with Heavily Pretreated Multiple Myeloma jnj.com ↗
Study results show that responses were durable and deepened over time – 58 percent of patients receiving teclistamab achieved a very good partial response (VGPR) or better, and 40 percent achieved a complete response (CR) or better at the RP2D. |
| 2020-12-05 | Janssen Research & Development, LLC | Results Updated Results from the Phase 1 Study of the BCMAxCD3 Bispecific Teclistamab Show Preliminary Efficacy in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma jnj.com ↗
In heavily pretreated patients, the overall response rate (ORR) with teclistamab was 73 percent (16/22) at the recommended subcutaneous (SC) Phase 2 dose (RP2D).[1] |
| 2020-12-05 | Janssen Research & Development, LLC | Results Updated Results from the Phase 1 Study of the BCMAxCD3 Bispecific Teclistamab Show Preliminary Efficacy in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma jnj.com ↗
In heavily pretreated patients, the overall response rate (ORR) with teclistamab was 73 percent (16/22) at the recommended subcutaneous (SC) Phase 2 dose (RP2D). |
| 2020-05-18 | Janssen Research & Development, LLC | Results Janssen Presents First Data from Phase 1 Study of BCMAxCD3 Bispecific Teclistamab in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma jnj.com ↗
Initial results suggest a manageable safety profile across all teclistamab doses evaluated. |
All press releases naming this drug 72 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 63 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Teclistamab | “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 ↗59“Teclistamab is a BCMA×CD3 bispecific T-cell engager (BiTE) administered via subcutaneous injection.” NCT07689149 ↗ “melphalan, teclistamab, darzalex” NCT05231629 ↗ |
| Known as | BCMAxCD3 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594505 ↗ |
| Known as | JNJ-64007957 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594505 ↗ |
| Known as | Tec | “Teclistamab (Tec)” NCT07079423 ↗ |
| Known as | Teclistamab cqyv | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594505 ↗ |
| Known as | Tecvayli | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594505 ↗ |
| Action | Deplete | “Teclistamab also depleted BCMA+ cells in bone marrow samples from MM patients” PMID 32956453 ↗ Sep 2020 |
| Modality | Monoclonal antibody | “Teclistamab is a B-cell maturation antigen × CD3 bispecific antibody” PMID 41886220 ↗ Mar 2026 |
| Route | Intravenous | “Participants will receive IV infusion of Teclistamab.” NCT03145181 ↗ |
| Target | TNFRSF17 | “Tumor necrosis factor receptor superfamily member 17 binding agent” CHEMBL4594505 ↗ |