By Fineline Cube 
France-based Sanofi (NASDAQ: SNY) announced that the European Commission has approved its anti-CD38 monoclonal antibody Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd regimen). This approval is for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplantation. This marks the first antibody-based therapy approved in the EU for this patient population.
Clinical Trial Results
The approval is based on Part 1 data from the Phase III GMMG-HD7 trial. The trial demonstrated that Sarclisa plus VRd significantly improved the rate of minimal residual disease (MRD) negativity at the end of the 18-week induction period (primary endpoint) and prolonged progression-free survival (PFS). The sustained MRD negativity rate was 53.1% in the Sarclisa-VRd group versus 38% in the control group. Overall survival data are still immature, and the safety profile was consistent with previous studies.
Global Approval and Significance
Sarclisa has now been approved in over 50 countries and regions, including the U.S., EU, Japan, and China, for the treatment of various forms of multiple myeloma. This approval further expands Sarclisa’s label to cover both transplant-eligible and transplant-ineligible NDMM patients across the treatment spectrum.-Fineline Info & Tech