Sanofi Wins FDA Approval for Wearable Injector Form of Blood Cancer Drug - Sanofi (NASDAQ:SNY)

The U.S.

Food and Drug Administration (FDA) on Friday approved Sanofi SA's (NASDAQ:SNY) subcutaneous Sarclisa Escena (isatuximab-irfc) in combination with standard-of-care regimens for multiple myeloma across all approved indications of the intravenous formulation.

The approval makes Sarclisa Escena the first anticancer therapy that can be administered through both an on-body injector (OBI) and manual subcutaneous injection.

Sarclisa is currently approved in the U.S. for three multiple myeloma indications.

Phase 3 Data Supported FDA Decision The FDA based its decision on data from multiple studies, including the pivotal Phase 3 IRAKLIA non-inferiority trial.