Sanofi's (SNY) Sarclisa sBLA Gets FDA's Priority Review Tag
SNYSanofi(SNY) zacks.com·2024-05-27 23:46

Sanofi (SNY) announced that the FDA has accepted the supplemental biologics license application (sBLA), seeking expanded use of its multiple myeloma drug, Sarclisa (isatuximab).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 regulator ...