Drugs / Isatuximab
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed plasma cell myeloma 3 milestones | |||||
| Filed | EU (EMA) | Sarclisa | plasma cell myeloma | 2020-10-29 | “was successfully validated by EMA and has been formally accepted for review.” sanofi.com ↗ |
| Filed | China (NMPA) | Sarclisa | plasma cell myeloma | — | “Beyond the US and the EU, regulatory submissions for Sarclisa in NDMM not eligible for ASCT are under review in Japan and in China.” sanofi.com ↗ |
| Filed | Japan (PMDA) | Sarclisa | plasma cell myeloma | — | “Beyond the US and the EU, regulatory submissions for Sarclisa in NDMM not eligible for ASCT are under review in Japan and in China.” sanofi.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 1 milestone | |||||
| Filed | EU (EMA) | Sarclisa | relapsed/refractory diffuse large B-cell lymphoma | — | “In the second quarter of 2019, the EMA accepted for review the Marketing Authorization Application for use of Sarclisa in combination with pom-dex” sanofi.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Sarclisa | — | 2020-05-30 | europa.eu ↗ |
Trials 90 · started per year
today
EU approved 2020
1
1
4
2
5
8
3
5
16
14
11
6
5
8
1
2010201120122013201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05862766 | Dec 2024 → Jan 2026 | anti-HLA hyperimmunization, transplant rejection | NYU Langone Health | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT05284032 | Nov 2022 → Jun 2024 | blood platelet disease, hematopoietic and lymphoid cell neoplasm | Firas El Chaer, MD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 113 trials | ||||||
| Phase 1 | NCT06203912 | Mar 2024 → May 2026 | plasma cell myeloma | Elvira Umyarova | Completed | No outcome recorded |
| Phase 1 | NCT05137054 | Aug 2022 → Mar 2028 expected | plasma cell myeloma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT04912427 | Apr → Dec 2022 | plasma cell myeloma | Washington University School of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04754945 | Apr 2021 → May 2027 expected | AL amyloidosis | Emory University | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04083898 | Apr 2020 → Mar 2023 | plasma cell myeloma | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 1 | NCT04045795 | Aug 2019 → Mar 2024 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03733717 | Oct 2018 → Sep 2020 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03530683 | May 2018 → Jul 2024 | acute myeloid leukemia, diffuse large B-cell lymphoma, plasma cell myeloma | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02513186 | Sep 2015 → Jan 2022 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT02514668 | Sep 2015 → Dec 2021 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT02283775 | May 2015 → May 2021 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT02332850 | Jan 2015 → Dec 2025 | plasma cell myeloma | Thomas Martin, MD | Completed | No outcome recorded |
| Phase 1 | NCT01749969 | Feb 2013 → Jun 2023 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1/214 trials · 1 met primary · 1 missed | ||||||
| Phase 1/2 | NCT07601100 | Sep 2026 → Jul 2029 expected | plasma cell myeloma | Dana-Farber Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07714512 | Jun 2026 → Jun 2028 expected | aplastic anemia | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07479979 | May 2026 → Jul 2027 expected | plasma cell myeloma | Natalie Callander | Recruiting | 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 | NCT07217184 | Jul 2021 → Apr 2025 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04643002 | Jan 2021 → Sep 2027 expected | plasma cell myeloma | Sanofi | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04294459 | Jun 2020 → May 2022 | immune system disorder | Sanofi | Terminated | No outcome recorded |
| Phase 1/2 | NCT04126200 | Oct 2019 → Apr 2025 overdue | plasma cell myeloma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03769181 | Dec 2018 → Nov 2022 | lymphoma | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03555149 | Sep 2018 → Sep 2022 | colorectal cancer | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03194867 | Feb 2018 → Apr 2023 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1/2 | NCT03367819 | Jan 2018 → Mar 2021 | non-small cell lung carcinoma, prostate cancer | Sanofi | Terminated | Missed primary |
| Phase 1/2 | NCT02812706 | Sep 2016 → Jul 2018 | plasma cell myeloma | Sanofi | Completed | No outcome recorded |
| Phase 1/2 | NCT01084252 | May 2010 → Dec 2018 | hematopoietic and lymphoid cell neoplasm | Sanofi | Completed | Met primary |
| Phase 246 trials · 3 met primary · 1 missed | ||||||
| Phase 2 | NCT07828522 | Oct 2026 → Oct 2027 expected | plasma cell myeloma | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07652905 | Sep 2026 → Jun 2029 expected | plasma cell leukemia | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT07585760 | Sep 2026 → May 2028 expected | plasma cell myeloma | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT06517017 | Oct 2025 → Nov 2026 expected | plasma cell leukemia, plasma cell myeloma | University of Utah | Recruiting | No outcome recorded |
| Phase 2 | NCT06832865 | Aug 2025 → Dec 2026 expected | refractory plasma cell neoplasm | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06762769 | Jun 2025 → Nov 2032 expected | smoldering plasma cell myeloma | University College, London | Recruiting | No outcome recorded |
| Phase 2 | NCT06356571 | Mar 2025 → Jan 2027 expected | plasma cell myeloma | Sanofi | Recruiting | No outcome recorded |
| Phase 2 | NCT05272826 | Dec 2024 → Mar 2028 expected | plasma cell myeloma | Canadian Myeloma Research Group | Recruiting | No outcome recorded |
| Phase 2 | NCT06648889 | Oct 2024 → Feb 2028 expected | T-cell acute lymphoblastic leukemia | Goethe University | Recruiting | No outcome recorded |
| Phase 2 | NCT05922501 | May 2024 → Dec 2028 expected | plasma cell myeloma | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05911321 | Dec 2023 → Jun 2025 overdue | plasma cell myeloma, refractory plasma cell neoplasm | UNC Lineberger Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05776979 | Aug 2023 → Dec 2027 expected | plasma cell myeloma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05873205 | Jul 2023 → Jun 2027 expected | hematopoietic and lymphoid system neoplasm | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05690984 | Jun 2023 → Sep 2026 overdue | plasma cell myeloma | Medical College of Wisconsin | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05704049 | Apr 2023 → Dec 2025 overdue | refractory plasma cell neoplasm | Sanofi | Active not recruiting | Met primary |
| Phase 2 | NCT05669989 | Apr 2023 → Nov 2026 expected | plasma cell myeloma | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05346809 | Mar 2023 → Sep 2026 overdue | Hodgkins lymphoma, non-Hodgkin lymphoma, plasma cell myeloma | Divaya Bhutani | Recruiting | No outcome recorded |
| Phase 2 | NCT05344833 | Jan 2023 → Dec 2030 expected | plasma cell myeloma | University of Illinois at Chicago | Recruiting | No outcome recorded |
| Phase 2 | NCT04943302 | Sep 2022 → Sep 2024 | AL amyloidosis | Tufts Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT05559827 | Sep 2022 → Oct 2026 expected | primary acquired red cell aplasia | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04850599 | Jun 2022 → Oct 2027 expected | plasma cell myeloma | OHSU Knight Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05298683 | May 2022 → Nov 2025 | impaired renal function disease, monoclonal paraproteinemia disease, plasma cell myeloma | Hellenic Society of Hematology | Unknown | No outcome recorded |
| Phase 2 | NCT05123131 | Apr 2022 → Jun 2025 overdue | plasma cell myeloma | Cancer Trials Ireland | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05147493 | Apr 2022 → Dec 2024 | impaired renal function disease, monoclonal paraproteinemia disease, plasma cell myeloma | Hellenic Society of Hematology | Unknown | No outcome recorded |
| Phase 2 | NCT05145400 | Feb 2022 → May 2033 expected | plasma cell myeloma | UNC Lineberger Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05066607 | Feb 2022 → Mar 2026 | AL amyloidosis | Intergroupe Francophone du Myelome | Unknown | No outcome recorded |
| Phase 2 | NCT04835129 | Jan 2022 → Apr 2027 expected | plasma cell myeloma | Medical College of Wisconsin | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04240054 | Nov 2021 → Dec 2029 expected | plasma cell myeloma | Medical College of Wisconsin | Recruiting | No outcome recorded |
| Phase 2 | NCT05114109 | Nov 2021 → Dec 2022 | Cryoglobulinemic vasculitis, monoclonal gammopathy of uncertain significance, plasma cell myeloma | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 2 | NCT04891809 | Oct 2021 → Dec 2027 expected | plasma cell myeloma | Study Group of Medical Tumour Therapy (AGMT) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04661033 | Sep 2021 → Jun 2023 | autoimmune hemolytic anemia, warm type | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04883242 | Jul 2021 → Dec 2026 expected | plasma cell myeloma | University of Washington | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04653246 | Jul 2021 → Dec 2025 overdue | plasma cell myeloma | Jacob Laubach, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04939844 | Jun 2021 → Aug 2024 | plasma cell myeloma | Oslo University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04763616 | Jun 2021 → Apr 2023 | mature T-cell and NK-cell non-Hodgkin lymphoma | Won Seog Kim | Completed | Met primary |
| Phase 2 | NCT04614558 | Jun 2021 → Apr 2026 overdue | monoclonal gammopathy | Columbia University | Recruiting | No outcome recorded |
| Phase 2 | NCT04558931 | Jun 2021 → Dec 2027 expected | plasma cell myeloma | Karolinska Institutet | Recruiting | No outcome recorded |
| Phase 2 | NCT04802031 | May 2021 → Nov 2022 | plasma cell myeloma | Thomas Martin, MD | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04965155 | Mar 2021 → Nov 2023 overdue | plasma cell myeloma | EMN Trial Office S.r.l. Impresa Sociale | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04287855 | Aug 2020 → Apr 2025 | plasma cell myeloma | Poitiers University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04430894 | Jul 2020 → Jul 2022 overdue | plasma cell myeloma | Massachusetts General Hospital | Active not recruiting | Missed primary |
| Phase 2 | NCT03860844 | Aug 2019 → Sep 2022 | acute lymphoblastic leukemia, acute myeloid leukemia | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03499808 | Jun 2018 → Aug 2023 | constipation disorder, diarrheal disease, lymph node disorder, macroglossia +2 | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 2 | NCT03104842 | Aug 2017 → May 2026 overdue | plasma cell myeloma | University Medical Center Hamburg-Eppendorf | Active not recruiting | Met primary |
| Phase 2 | NCT02999633 | Mar → Nov 2017 | T lymphoblastic leukemia/lymphoma, precursor T-cell acute lymphoblastic leukemia | Sanofi | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02960555 | Feb 2017 → Apr 2027 expected | smoldering plasma cell myeloma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT07732712 | Jan 2027 → Dec 2028 expected | plasma cell myeloma | The Affiliated People's Hospital of Ningbo University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06860269 | May 2025 → Mar 2035 expected | acute lymphoblastic leukemia | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05665140 | Feb 2023 → Aug 2027 expected | plasma cell myeloma | University Hopsital Schleswig Holstein Campus Lübeck | Recruiting | No outcome recorded |
| Phase 311 trials · 6 met primary · 1 missed | ||||||
| Phase 3 | NCT07624513 | Aug 2026 → Oct 2033 expected | plasma cell myeloma | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT06216158 | Apr 2024 → Dec 2028 expected | plasma cell myeloma | University of Heidelberg Medical Center | Recruiting | No outcome recorded |
| Phase 3 | NCT05804032 | Apr 2023 → Jan 2026 | plasma cell myeloma | University of Heidelberg Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT05558319 | Nov 2022 → Apr 2027 expected | plasma cell myeloma | PETHEMA Foundation | Recruiting | No outcome recorded |
| Phase 3 | NCT05405166 | Jun 2022 → Nov 2024 overdue | plasma cell myeloma | Sanofi | Active not recruiting | Met primary |
| Phase 3 | NCT04934475 | Dec 2021 → Sep 2024 overdue | plasma cell myeloma | Intergroupe Francophone du Myelome | Active not recruiting | Missed primary |
| Phase 3 | NCT04483739 | Sep 2020 → Jul 2025 overdue | plasma cell myeloma | European Myeloma Network B.V. | Active not recruiting | Met primary |
| Phase 3 | NCT03617731 | Oct 2018 → Jun 2028 expected | plasma cell myeloma | University of Heidelberg Medical Center | Active not recruiting | Met primary |
| Phase 3 | NCT03319667 | Dec 2017 → Apr 2027 expected | plasma cell myeloma | Sanofi | Active not recruiting | Met primary |
| Phase 3 | NCT03275285 | Oct 2017 → Jan 2022 | plasma cell myeloma | Sanofi | Completed | Met primary |
| Phase 3 | NCT02990338 | Dec 2016 → Nov 2018 | plasma cell myeloma | Sanofi | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT07334535 | Jan 2026 → Jul 2028 expected | plasma cell myeloma | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1/2 | NCT07600151 Background | Dec 2026 → Sep 2036 expected | plasma cell myeloma | University Medical Center Hamburg-Eppendorf | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT03989414 Background | Sep 2019 → Nov 2026 expected | plasma cell myeloma | Celgene Corporation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07053436 Comparator | Apr 2026 → Oct 2035 expected | — | Multiple Myeloma Research Consortium | Recruiting | No outcome recorded |
| Phase 2 | NCT07045909 Background | Jun 2025 → Mar 2028 expected | plasma cell myeloma | PETHEMA Foundation | Recruiting | No outcome recorded |
| Phase 3 | NCT06182774 Comparator | Apr 2024 → Jan 2032 expected | plasma cell myeloma | Canadian Cancer Trials Group | Recruiting | 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 | NCT04751877 Background | Jul 2021 → Jun 2024 overdue | plasma cell myeloma | Poitiers University Hospital | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 34
| Date | Issuer | Release |
|---|---|---|
| 2026-07-10 | Sanofi | Regulatory Press Release: Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector sanofi.com ↗
The US Food and Drug Administration (FDA) has approved subcutaneous (SC) Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all existing indications of Sarclisa intravenous (IV) formulation. |
| 2026-06-19 | Sanofi | Regulatory Press Release: Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma sanofi.com ↗
The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). |
| 2026-06-08 | Sanofi | Regulatory Press Release: Sanofi’s Sarclisa subcutaneous approved in the EU as the first anticancer treatment administered via an on-body injector sanofi.com ↗
The European Commission has approved Sarclisa (isatuximab) subcutaneous (SC) in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all existing indications for Sarclisa intravenous (IV) formulation. |
| 2026-04-22 | Sanofi | Regulatory Press Release: Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US sanofi.com ↗
The revised target action date for the FDA decision is July 23, 2026. |
| 2026-03-27 | Sanofi | Regulatory Press Release: Sanofi’s Sarclisa subcutaneous formulation administered via on-body injector recommended for EU approval by the CHMP to treat multiple myeloma sanofi.com ↗
Sanofi’s Sarclisa subcutaneous formulation administered via on-body injector recommended for EU approval by the CHMP to treat multiple myeloma |
| 2025-07-25 | Sanofi | Regulatory Press Release: Sanofi’s Sarclisa approved in the EU for the treatment of transplant-eligible newly diagnosed multiple myeloma sanofi.com ↗
Sanofi’s Sarclisa approved in the EU for the treatment of transplant-eligible newly diagnosed multiple myeloma |
| 2025-06-23 | Sanofi | Regulatory Press Release: Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma sanofi.com ↗
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. |
| 2025-06-03 | Sanofi | Results Press Release: ASCO: new Sarclisa data support subcutaneous administration with on-body injector sanofi.com ↗
Objective response rate (ORR) with Sarclisa SC-Pd was 71.1% compared to 70.5% with Sarclisa IV-Pd, establishing non-inferiority (risk ratio [RR] 1.008; 95% confidence interval [CI]: 0.903-1.126; p=0.0006). |
| 2025-02-25 | Sanofi | Regulatory Press Release: Sarclisa approved in Japan for patients with newly diagnosed multiple myeloma sanofi.com ↗
The Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Sarclisa, in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) based on data from the IMROZ phase 3 study. |
| 2025-01-31 | Sanofi | Regulatory Press Release: Sarclisa is the first anti-CD38 treatment in combination with standard-of-care VRd approved in China for patients with newly diagnosed multiple myeloma ineligible for transplant sanofi.com ↗
Sarclisa is the first anti-CD38 treatment in combination with standard-of-care VRd approved in China for patients with newly diagnosed multiple myeloma ineligible for transplant |
| 2025-01-22 | Sanofi | Regulatory Press Release: Sarclisa approved in the EU as the first anti-CD38 therapy in combination with standard-of-care VRd to treat transplant-ineligible newly diagnosed multiple myeloma sanofi.com ↗
With the expanded marketing authorization, Sarclisa is the first anti-CD38 therapy in combination with VRd in this patient population in the EU. |
| 2025-01-13 | Sanofi | Regulatory Press Release: Sarclisa obtains first approval in China for the treatment of adult patients with relapsed or refractory multiple myeloma sanofi.com ↗
Sarclisa obtains first approval in China for the treatment of adult patients with relapsed or refractory multiple myeloma |
| 2025-01-09 | Sanofi | Results Press Release: New Sarclisa subcutaneous formulation met co-primary endpoints in the IRAKLIA phase 3 study in multiple myeloma sanofi.com ↗
Sarclisa SC formulation added to Pd for the treatment of R/R MM met the co-primary endpoints in the IRAKLIA phase 3 study, demonstrating non-inferiority compared to Sarclisa IV |
| 2024-12-09 | Sanofi | Results Press Release: ASH: Sarclisa combinations demonstrated significant benefits in newly diagnosed multiple myeloma patients sanofi.com ↗
New analysis from the IMROZ phase 3 study of Sarclisa-VRd demonstrated higher and sustained MRD negativity rates in transplant- ineligible NDMM patients versus VRd alone |
| 2024-11-14 | Sanofi | Regulatory Press Release: Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma sanofi.com ↗
Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma |
| 2024-09-20 | Sanofi | Regulatory Press Release: Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma not eligible for transplant sanofi.com ↗
Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma not eligible for transplant |
| 2024-08-08 | Sanofi | Results Press Release: Sarclisa induction treatment demonstrated significantly improved progression-free survival in patients with newly diagnosed multiple myeloma eligible for transplant sanofi.com ↗
Sarclisa induction treatment demonstrated significantly improved progression-free survival in patients with newly diagnosed multiple myeloma eligible for transplant |
| 2024-06-03 | Sanofi | Results Press Release: ASCO: Sarclisa is first anti-CD38 to significantly improve progression-free survival in combination with VRd for newly diagnosed transplant-ineligible multiple myeloma in phase 3 sanofi.com ↗
ASCO: Sarclisa is first anti-CD38 to significantly improve progression-free survival in combination with VRd for newly diagnosed transplant-ineligible multiple myeloma in phase 3 |
| 2024-05-27 | Sanofi | Regulatory Press Release: Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma sanofi.com ↗
Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma |
| 2023-12-11 | Sanofi | Results Press Release: Sarclisa® (isatuximab) plus KRd significantly improved rate of minimal residual disease negativity in transplant-eligible patients with newly diagnosed multiple myeloma versus KRd alone sanofi.com ↗
Phase 3 data showed Sarclisa added to carfilzomib, lenalidomide and dexamethasone (KRd) in patients with newly diagnosed, transplant-eligible multiple myeloma resulted in 77% of patients achieving minimal residual disease (MRD) negativity after consolidation therapy, detected with a sensitivity of 10 -5 |
| 2023-12-07 | Sanofi | Results Press Release: Sarclisa® (isatuximab) Phase 3 trial met primary endpoint of progression free survival in patients with newly diagnosed multiple myeloma not eligible for transplant sanofi.com ↗
This is also the second Phase 3 trial investigating Sarclisa in newly diagnosed patients to show superiority versus standard of care. |
| 2022-05-15 | Sanofi | Results Press Release: Sarclisa® (isatuximab) combination provides unprecedented median progression free survival in patients with relapsed multiple myeloma receiving a proteasome inhibitor therapy sanofi.com ↗
The median progression free survival, increased from 19.2 months to 35.7 months when Sarclisa was added to carfilzomib and dexamethasone |
| 2021-12-11 | Sanofi | Results Sarclisa® (isatuximab) trial is first Phase 3 study to meet primary endpoint of minimal residual disease negativity in transplant-eligible patients with newly diagnosed multiple myeloma sanofi.com ↗
The Phase 3 HD7 trial, conducted by the German-Speaking Myeloma Multicenter Group (GMMG), met the primary endpoint, the rate of minimal residual disease (MRD) negativity after induction therapy and before transplant in patients with newly diagnosed multiple myeloma (MM) treated with Sarclisa ® (isatuximab) in combination with lenalidomide, bortezomib and dexamethasone (RVd). |
| 2021-05-19 | Sanofi | Results Sanofi to showcase data from its transformative oncology pipeline at 2021 ASCO Meeting sanofi.com ↗
Longer term data and new analyses for Sarclisa ® (isatuximab-irfc) further strengthen its efficacy profile, including for elderly patients and patients with high - risk cytogenetic abnormalities |
| 2021-04-19 | Sanofi | Regulatory European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma sanofi.com ↗
Today, the European Commission (EC) approved Sarclisa ® (isatuximab) in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with relapsed multiple myeloma who have received at least one prior therapy. |
| 2021-03-31 | Sanofi | Regulatory FDA approves Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has approved Sarclisa ® (isatuximab) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. |
| 2021-02-26 | Sanofi | Regulatory Media Update: CHMP recommends approval of Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of relapsed multiple myeloma sanofi.com ↗
CHMP recommends approval of Sarclisa ® (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of relapsed multiple myeloma |
| 2020-06-02 | Sanofi | Results Sarclisa® (isatuximab) combination therapy demonstrated superior progression free survival and clinically meaningful depth of response in patients with relapsed multiple myeloma sanofi.com ↗
Sarclisa added to carfilzomib and dexamethasone (Sarclisa combination) reduced risk of disease progression or death by 47% versus standard of care carfilzomib and dexamethasone (Kd) alone |
| 2020-06-02 | Sanofi | Regulatory European Commission approves Sarclisa® (isatuximab) for adults with relapsed and refractory multiple myeloma sanofi.com ↗
The European Commission (EC) has approved Sarclisa ® (isatuximab) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. |
| 2020-05-12 | Sanofi | Results Sarclisa® (isatuximab) Phase 3 IKEMA trial meets primary endpoint early in patients with relapsed multiple myeloma sanofi.com ↗
The Phase 3 IKEMA clinical trial evaluating Sarclisa ® (isatuximab) added to carfilzomib and dexamethasone met the primary endpoint at its first planned interim analysis |
| 2020-03-27 | Sanofi | Regulatory Sanofi receives positive CHMP opinion for Sarclisa® (isatuximab) for the treatment of relapsed and refractory multiple myeloma sanofi.com ↗
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Sarclisa ® (isatuximab). |
| 2020-03-02 | Sanofi | Regulatory Sanofi : FDA approves Sarclisa® (isatuximab-irfc) for patients with relapsed refractory multiple myeloma sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has approved Sarclisa ® (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. |
| 2014-11-24 | AbbVie | Results ImmunoGen, Inc. Announces Clinical and Preclinical Data Presentations at Upcoming 56th ASH Annual Meeting and Exposition abbvie.com ↗
SAR650984 (SAR) Directly Promotes Homotypic Adhesion-Related Multiple Myeloma (MM) Cell Death and SAR-Induced Anti-MM Activities Are Enhanced By Pomalidomide, More Potently Than Lenalidomide. |
| 2013-12-09 | AbbVie | Results ImmunoGen, Inc. Announces Favorable Initial Safety and Response Findings for CD38-Targeting Anticancer Compound, SAR650984 abbvie.com ↗
Among these 22 patients, the best response to therapy reported was: 2 complete response (CR), 4 partial response (PR), 2 minimal response (MR), 9 stable disease (SD), and 5 progressive disease (PD). |
All press releases naming this drug 35 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 99 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Isatuximab | “Isatuximab-KRd with Autologous Stem Cell Transplant” NCT07053436 ↗ |
| Known as | ISA | “Isatuximab (ISA) is another IgG1 κ mAb that binds selectively to a unique epitope on the human CD38 receptor and has anti plasma cells activity via multiple mechanisms of action.” NCT05066607 ↗3“The study will test a new combination of 3 drugs: Isatuximab (Isa), Iberdomide (Iber) and Dexamethasone (Dex), in patients who have intermediate or high risk smouldering myeloma.” NCT06762769 ↗ “The anti-CD38 antibody isatuximab (ISA, Sarclisa®, Immunogen, Sanofi-Aventis) is currently approved to treat myeloma patients in 2nd line.” NCT06860269 ↗ “anti-CD38 monoclonal antibody (Daratumumab [D] or Isatuximab [Isa])” NCT07045909 ↗ |
| Known as | Isatuximab-Irfc | “Isatuximab-Irfc 20 MG/ML [Sarclisa]” NCT04891809 ↗ |
| Known as | SAR650984 | “A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab (SAR650984) in Patients Awaiting Kidney Transplantation” NCT04294459 ↗10“Isatuximab (SAR650984) in combination with Bortezomib (Velcade®), Lenalidomide and Dexamethasone” NCT03319667 ↗ “Drug: Isatuximab SAR650984” NCT02999633 ↗ “Drug: isatuximab SAR650984” NCT03769181 ↗ “isatuximab SAR650984 IV” NCT04045795 ↗ “SAR650984 (Isatuximab)” NCT02513186 ↗ “Isatuximab (SAR650984)” NCT03104842 ↗ “SAR650984 (Isatuximab)” NCT02283775 ↗ “Isatuximab SAR650984” NCT02812706 ↗ “Isatuximab SAR650984” NCT04661033 ↗ “Isatuximab SAR650984” NCT03194867 ↗ |
| Known as | Sarclisa | “The anti-CD38 antibody isatuximab (ISA, Sarclisa®, Immunogen, Sanofi-Aventis) is currently approved to treat myeloma patients in 2nd line.” NCT06860269 ↗ |
| Action | Inhibit | “Monoclonal antibodies, such as isatuximab, may interfere with the ability of cancer cells to grow and spread.” NCT03499808 ↗ |
| Modality | Monoclonal antibody | “A Phase 2 dose-finding study evaluated isatuximab, an anti-CD38 monoclonal antibody, in relapsed/refractory multiple myeloma (RRMM; NCT01084252).” PMID 32409691 ↗ May 2020 |
| Route | Intravenous | “Route of administration: intravenous” NCT01749969 ↗ |
| Target | CD38 | “anti-CD38 monoclonal antibody isatuximab” PMID 28483761 ↗ May 2017 |