Press Release: Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma

Core Viewpoint - Sarclisa has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for approval in combination with VRd for treating transplant-ineligible newly diagnosed multiple myeloma (NDMM) patients, potentially establishing a new standard of care in the EU [1][2][4] Group 1: Approval and Clinical Study - The CHMP's recommendation is based on the IMROZ phase 3 study, which demonstrated that Sarclisa combined with VRd significantly improved progression-free survival (PFS) compared to VRd alone [1][4] - If approved, Sarclisa would be the first anti-CD38 therapy available in the EU for this patient population [1] - The IMROZ study is the first global phase 3 study of a CD38 monoclonal antibody in combination with standard-of-care VRd [4] Group 2: Current Approvals and Indications - Sarclisa is currently approved in over 50 countries, including the US and EU, for treating certain adult patients with relapsed or refractory multiple myeloma (MM) [3][6] - In the US, Sarclisa is also approved in combination with VRd as a first-line treatment for adult patients with NDMM who are not eligible for autologous stem cell transplant [6] Group 3: Company Strategy and Future Directions - Sanofi is advancing Sarclisa as part of a patient-centric clinical development program, which includes several phase 2 and phase 3 studies across the multiple myeloma treatment continuum [7] - The company is also exploring a subcutaneous administration method for Sarclisa in clinical studies [7] - Sanofi aims to become the leading immunoscience company globally, focusing on difficult-to-treat cancers, including multiple myeloma [8]