Healthcare
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 mindThe 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 USEfficacy of Sarclisa now available in SC formulation with innovative OBI across appro
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Sanofi's subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector 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 Ailawadhi, MD, Professor of Medicine, Division of Hematology/Oncology at Mayo Clinic Florida, US, and the 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." The studies were conducted using Enable Injections' hands-free OBI, an automated injector designed to deliver subcutaneously high-volume medicines with the push of a button, to administer Sarclisa Escena. The OBI uses a retractable 30g needle that is shorter and thinner compared to the needles commonly used for large-volume injections. The approval of Sarclisa Escena with Enable Injections' CirCLIQ OBI – developed using the enFuse® platform – offers the potential to change the overall patient experience in MM treatment.