Sarclisa recommended for EU approval in newly diagnosed multiple myeloma
Ella Day | June 24, 2025 | News story | Research and Development | Committee for Medicinal Products for Human USE, EU, European Commission, European Medicines Agency, German-speaking Myeloma Multicenter Group, Oncology, Sanofi, blood cancer, monoclonal antibody
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi’s Sarclisa (isatuximab) for approval in combination with bortezomib, lenalidomide and dexamethasone (VRd) for induction treatment in adults with newly diagnosed multiple myeloma (NDMM) eligible for stem cell transplant.
If approved, this would mark Sarclisa’s fourth indication in the EU and its second global approval in the front-line setting. The recommendation is based on part one of the GMMG-HD7 phase 3 study, which showed that Sarclisa-VRd significantly improved rates of minimal residual disease (MRD) negativity and progression-free survival versus VRd alone. It demonstrated the highest MRD negativity rates seen with a CD38 monoclonal antibody using a VRd backbone in transplant-eligible NDMM patients.
Olivier Nataf, global head of oncology at Sanofi, said the therapy “has the potential to improve long-term outcomes and deepen responses at a critical juncture in treatment”.
Conducted by the German-speaking Myeloma Multicenter Group (GMMG), the study enrolled 662 patients across 67 German sites. Sarclisa was administered intravenously weekly for the first four weeks and bi-weekly for the rest of the induction period.
Sarclisa is currently approved in more than 50 countries for relapsed or refractory multiple myeloma and transplant-ineligible NDMM. If approved for transplant-eligible patients, Sarclisa-VRd would offer a new option to achieve deeper disease responses before stem cell transplant. A final decision by the European Commission is anticipated in the next few months.
Ella Day
24/6/25
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