Press Release: Sanofi's subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector

Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector

Sarclisa Escena administered via the CirCLIQ ® on-body injector (OBI) offers a treatment experience designed with patients and HCPs in mind

The first anticancer treatment to be administered through an OBI, and the first MM treatment available by both SC OBI and manual SC administration in the US

Efficacy of Sarclisa now available in SC formulation with innovative OBI across approved combinations and lines of therapy

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

With the approval, Sarclisa Escena is the first anticancer treatment to be administered through both an on-body injector (OBI) 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.

“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 Sikander A...