Sarclisa Receives CHMP Recommendation for Approval in EU for Newly Diagnosed Multiple Myeloma Treatment in Eligible Patients for Autologous Transplant.
ByAinvest
Monday, Jun 23, 2025 1:02 am ET1min read
GMM--
Sarclisa, a drug used to treat multiple myeloma, has been recommended for approval in the EU by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the treatment of newly diagnosed multiple myeloma in eligible patients undergoing stem cell transplantation. The recommendation is based on a Phase 3 study, GMMG-HD7, which showed that adding Sarclisa to VRd induction treatment significantly improved minimal residual disease negativity and prolonged progression-free survival compared to VRd alone. If approved, this would be Sarclisa's fourth indication in the EU and second in first-line globally.

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