Sanofi: positive CHMP opinion for Sarclisa in myeloma
(CercleFinance.com) - Sanofi announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on its marketing authorization application for Sarclisa (isatuximab), in combination with bortezomib, lenalidomide and dexamethasone (VRd protocol), for the first-line treatment of newly diagnosed multiple myeloma (MMND) in adults not eligible for autologous stem cell transplantation.
A final decision is expected in the coming months.
A final decision is expected in the coming months.
If approved, Sanofi says that Sarclisa, in combination with the VRd protocol, could become a new reference therapeutic approach for patients in the EU, in addition to helping to fill an important therapeutic gap in the sphere of multiple myeloma and potentially becoming the reference anti-CD38.
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