Sanofi's Sarclisa Escena Subcutaneous Approved in US by FDA
The U.S. Food and Drug Administration (FDA) has approved Sanofi's subcutaneous Sarclisa Escena, marking the first anticancer treatment administered via an on-body injector.
Paris, July 10, 2026 – The U.S. Food and Drug Administration (FDA) has approved Sanofi’s subcutaneous (SC) Sarclisa Escena for the treatment of multiple myeloma (MM). This approval makes Sarclisa Escena the first anticancer therapy that can be administered via both an on-body injector (OBI) and manual SC administration.
The FDA approval was based on data from multiple studies, including the pivotal phase 3 IRAKLIA study. This study demonstrated that Sarclisa Escena administered subcutaneously via an OBI showed comparable efficacy, pharmacokinetics, and safety to the intravenous (IV) infusion. The OBI also resulted in a significantly shorter treatment time and fewer infusion-related reactions.
„Multiple myeloma is a malignancy that often requires frequent IV infusions or manual subcutaneous injections. Treatment administration can be a cumbersome experience for patients, while also placing a strain on providers by requiring physical effort to push high-resistance syringes for several minutes,” said Dr. Sikander Ailawadhi, Professor of Medicine at Mayo Clinic Florida, US, and principal investigator of the IRAKLIA study. „The comparable efficacy observed across multiple studies and the patient-centric design of the OBI offers an opportunity to impact the patient experience while upholding Sarclisa’s consistent efficacy.“
This new administration method allows healthcare providers to offer patients an effective treatment option with a user-friendly delivery system. Sanofi anticipates that this will significantly improve the patient experience and reduce the burden on healthcare systems by streamlining the treatment process.