By Fineline Cube 
France major Sanofi (NASDAQ: SNY) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended market approval for Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd). The recommendation is for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant.
Current Approvals
Sarclisa is currently approved in the EU for three indications across different lines of therapy for adult patients with relapsed and/or refractory (R/R) multiple myeloma (MM) and for patients with NDMM who are not eligible for transplant.
Clinical Trial Basis
The positive recommendation from the CHMP is based on results from the Phase III GMMG-HD7 study. The trial achieved its primary endpoint of minimal residual disease (MRD) negativity after induction therapy and before transplant in patients with NDMM.
Regulatory Timeline
The European Commission (EC) is expected to issue a final decision on the approval of Sarclisa for this new indication in the coming months.-Fineline Info & Tech