Sanofi announces subcutaneous Sarclisa Escena approved in U.S.

The U.S. Food and Drug Administration has approved subcutaneous Sarclisa Escena in combination with standard-of-care regimens for the treatment of patients with multiple myeloma across all existing indications of Sarclisa intravenous formulation, Sanofi announced. "With the approval, Sarclisa Escena is the first anticancer treatment to be administered through both an on-body injector and manual SC administration. The FDA approval was supported by multiple studies, including the pivotal IRAKLIA phase 3 non-inferiority study, which demonstrated Sarclisa Escena administered subcutaneously via an OBI provided similar efficacy, pharmacokinetics and safety compared to IV infusion, along with a significantly shorter treatment time and fewer infusion-related reactions," the company stated.