India, June 23 -- French drug major Sanofi S.A. (SNYNF,SNY) announced Monday that Sarclisa (isatuximab) has been recommended for European Union approval by the Committee for Medicinal Products for Human Use or CHMP to treat transplant-eligible newly diagnosed multiple myeloma, based on GMMG-HD7 phase 3 study results. A final decision is expected in the coming months.
The European Medicines Agency's CHMP has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma or NDMM, who are eligible for autologous stem cell transplant.
The positive CHMP opinion is based on part one results ...