India, July 10 -- French drug major Sanofi SA (SNYNF,SNY) announced Friday that the US Food and Drug Administration (FDA) has approved subcutaneous (SC) Sarclisa Escena administered via the CirCLIQ on-body injector (OBI) for the treatment of patients with multiple myeloma (MM).
With the approval, Sarclisa Escena is the first anticancer treatment to be administered through OBI, and first MM treatment available by both SC OBI and manual SC administration in the US.
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 ...