Sanofi’s Sarclisa approved in the EU for the treatment of transplant-eligible newly diagnosed multiple myeloma
Executive Summary
Approval based on GMMG-HD7 phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD negativity benefit and prolonged PFS compared to VRd alone.
At the cut-off date and with a median follow-up time of 49.31 months, the study demonstrated a significant improvement in MRD negativity for patients who received induction treatment with isatuximab in combination with VRd vs. VRd alone: OR = 1.84 (95% CI: 1.35 to 2.51; p<0.0001).
The MRD negativity rate at the end of induction in the IVRd group was 50.5% (95% CI: 0.4493 to 0.5597), compared to 35.6% (95% CI: 0.3049 to 0.4107) in the VRd group, demonstrating a 14.8% increase in MRD negativity upon addition of isatuximab to the VRd triplet. This data was supported by PFS data.
Quote: “We have been on a mission to accelerate Sarclisa’s clinical development program with the hope to bring this important medicine to as many people as possible living with multiple myeloma,” said Olivier Nataf, Global Head of Oncology at Sanofi. “Today’s decision represents a prime example of those efforts, and most importantly, paves the way for Sarclisa to potentially become accessible to even more patients in the EU, regardless of transplant eligibility or line of therapy.”.
