July 10 (Reuters) - The U.S. Food and Drug Administration said on Friday it has approved Sanofi's blood cancer drug, Sarclisa, which can be given under the skin through a wearable injector, offering ...
FDA clears subcutaneous Sarclisa Escena for multiple myeloma, showing comparable overall response rates to IV delivery.
Approval covers all current IV isatuximab indications and introduces the first oncology product labeled for both OBI and manual SC administration. IRAKLIA (NCT05405166) established noninferiority of ...
Regulatory clearance adds a 1,400-mg subcutaneous CD38 antibody option using CirCLIQ on-body delivery or provider-administered injection, maintaining the same active medicine as the IV formulation.
Subcutaneous isatuximab is now approved with pomalidomide/dexamethasone, carfilzomib/dexamethasone, and bortezomib/lenalidomide/dexamethasone, aligning SC ...