EMA Committee Recommends Approval of Sarclisa-VRd Induction in Newly Diagnosed Multiple Myeloma Patients Eligible for Transplant

EMA Committee Recommends Approval of Sarclisa-VRd Induction in Newly Diagnosed Multiple Myeloma Patients Eligible for Transplant

(IN BRIEF) The CHMP has recommended EU approval of Sarclisa alongside VRd for transplant-eligible NDMM, based on GMMG-HD7 trial results showing superior MRD negativity and PFS compared to VRd alone. This potential label extension would mark Sarclisa’s fourth EU approval and its second front-line use worldwide. The pivotal, two-part phase 3 study enrolled 662 patients, demonstrating deep, rapid responses with the anti-CD38 combination and setting new benchmarks for MRD negativity both after induction and following transplant. Final EU sign-off is expected in the coming months.

(PRESS RELEASE) PARIS, 23-Jun-2025 — /EuropaWire/ — The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a favorable opinion for extending the use of Sarclisa (isatuximab) in adults with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. The recommendation covers Sarclisa in combination with bortezomib, lenalidomide and dexamethasone (“VRd”) as an induction regimen. A final decision from the European Commission is anticipated within the next few months.

This positive advice hinges on data from the GMMG-HD7 Phase 3 trial (NCT03617731), presented at the 2024 ASH Annual Meeting and later published in the Journal of Clinical Oncology. In part 1 of the study, adding Sarclisa to VRd significantly increased the rate of minimal residual disease (MRD) negativity after induction and delivered a marked improvement in progression-free survival (PFS) versus VRd alone—regardless of subsequent maintenance therapy and without requiring consolidation.

Among CD38-directed antibodies tested with VRd in transplant-eligible NDMM, Sarclisa-VRd achieved the highest post-induction and post-transplant MRD negativity rates observed to date. If sanctioned, this would become Sarclisa’s fourth EU approval and its second front-line indication globally, further solidifying its emerging role early in the treatment paradigm.

Sarclisa is already authorized in three EU settings for adults with relapsed/refractory multiple myeloma and for NDMM patients ineligible for transplant. The ongoing GMMG-HD7 trial is a two-part, open-label, randomized, multicenter study conducted by the German-speaking Myeloma Multicenter Group in collaboration with Sanofi. It enrolled 662 transplant-eligible NDMM patients across 67 German sites. In part 1, all participants received three 42-day cycles of VRd, with one arm also receiving weekly then biweekly Sarclisa infusions (10 mg/kg). Part 2 will re-randomize patients post-transplant to Sarclisa plus lenalidomide maintenance versus lenalidomide alone, with PFS as the key endpoint.

About Sarclisa
Sarclisa (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple treatment lines for MM. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US, EU and Japan in combination with pomalidomide and dexamethasone for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last therapy; this combination is also approved in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Based on the IKEMA phase 3 study, Sarclisa is also approved in more than 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received one to three prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy. In the US, EU, UK, and China, Sarclisa is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. In Japan, Sarclisa is approved in combination with VRd as a front-line treatment option regardless of transplant eligibility.

At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need.

For more information on Sarclisa clinical studies, please visit www.clinicaltrials.gov.

About the German-speaking Myeloma Multicenter Group
GMMG is the largest study group focusing on MM in Germany, with headquarters based in Heidelberg. Within the last 20+ years, the GMMG study group has performed numerous studies including five randomized, multicenter phase 3 studies with 4,000 patients enrolled from about 90 participating and cotreating centers throughout Germany. The overall goal of GMMG is to generate improved therapies for myeloma patients through the development and testing of novel and personalized, genome- and signaling driven treatment strategies. The GMMG has set itself the goal of achieving further approvals for effective antibody-based drug combinations for the first-line treatment of myeloma patients, in which antibody-based treatment regimens have been integrated into seven GMMG study concepts (CONCEPT, DANTE, DADA, HD6, HD7, HD8, HD9 and HD10).

About Sanofi
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SOURCE: Sanofi