Sanofi's Sarclisa Approved in the EU for Multiple Myeloma Treatment

SEC Filing 6-K (0001193125-25-170077)

In July 2025, Sanofi announced that its drug Sarclisa (isatuximab) has been approved by the European Commission for the treatment of transplant-eligible newly diagnosed multiple myeloma (NDMM). This approval is based on the GMMG-HD7 phase 3 study, which demonstrated that Sarclisa, in combination with bortezomib, lenalidomide, and dexamethasone (VRd), significantly improved minimal residual disease (MRD) negativity and prolonged progression-free survival (PFS) compared to VRd alone. The study showed that 53.1% of patients receiving Sarclisa-VRd experienced continued MRD negativity, compared to 38% in the control arm. This approval marks a significant milestone in Sanofi's efforts to expand the use of Sarclisa across all lines of therapy for multiple myeloma, regardless of transplant eligibility.