Sarclisa Gains EU Recommendation for Multiple Myeloma Treatment

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed Sarclisa for EU approval. This is for its use in combination with VRd as induction therapy in newly diagnosed, transplant-eligible multiple myeloma (NDMM) patients. The decision is based on phase 3 study GMMG-HD7, showing significant improvements in MRD negativity and progression-free survival (PFS) compared to VRd alone.

If confirmed, this will mark Sarclisa's fourth EU indication and its second in the global front-line setting. The study demonstrated the highest MRD negativity rates using an anti-CD38 regimen in these patients. Approval would offer a new treatment option with potential for enhanced long-term outcomes.