Sanofi's (SNY) Sarclisa sBLA Gets FDA's Priority Review Tag

The sBLA seeks approval for Sarclisa in combination with Velcade (bortezomib), Bristol-Myers' (BMY) Revlimid (lenalidomide) and dexamethasone (VRd) for the treatment of patients with newly diagnosed multiple myeloma (NDMM) who are transplant-ineligible. With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected on Sep 27, 2024. A similar regulatory application is also currently under review in the European Union. The sBLA and the application in the EU were based on ...