Sanofi's subcutaneous Sarclisa approved in US for on-body injector administration

Paris, July 10, 2026 – Sanofi announced today that the US Food and Drug Administration (FDA) has approved subcutaneous (SC) Sarclisa (isatuximab-irfc) Escena. This formulation is indicated for the treatment of patients with multiple myeloma (MM) in combination with standard-of-care regimens across all existing indications of the intravenous (IV) Sarclisa formulation.

With this approval, Sarclisa Escena becomes the first anticancer treatment to be administered via an on-body injector (OBI). It is also the first MM treatment available in the US for both SC OBI and manual SC administration.

The FDA approval was supported by multiple studies, including the pivotal phase 3 IRAKLIA study. This study demonstrated that Sarclisa Escena administered subcutaneously via an OBI provided similar efficacy, pharmacokinetics, and safety compared to IV infusion. The OBI method also resulted in 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," said Dr. Sikander Ailawadhi, Professor of Medicine at Mayo Clinic Florida. "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."

Sanofi stated that the approval of Sarclisa Escena with the CirCLIQ OBI, developed using Enable Injections' technology, has the potential to change the overall patient experience in MM treatment. Furthermore, the system may streamline the administration process for healthcare providers.