FDA clears Sanofi's Sarclisa Escena via on-body injector for myeloma

The U.S. Food and Drug Administration has approved Sanofi's (NASDAQ: SNY) subcutaneous Sarclisa Escena (isatuximab-irfc) for the treatment of multiple myeloma, making it the first anticancer treatment administered through an on-body injector (OBI), according to a company press release dated July 10, 2026.

The approval covers use in combination with standard-of-care regimens across all existing indications previously approved for the intravenous formulation of Sarclisa, including newly diagnosed and relapsed or refractory multiple myeloma. Sarclisa Escena is delivered via Enable Injections' CirCLIQ OBI, developed on the enFuse platform, and is also available through manual subcutaneous administration.

The FDA approval was supported by the pivotal IRAKLIA phase 3 non-inferiority study, which compared subcutaneous Sarclisa Escena administered via OBI against intravenous Sarclisa. The study found an objective response rate of 71.1% in the subcutaneous OBI group versus 70.5% in the intravenous group, meeting non-inferiority criteria. Systemic administration reactions occurred in 1.5% of patients in the subcutaneous group, compared with 25% in the intravenous group. Injection site reactions occurred in 0.4% of OBI injections, with nearly all classified as grade 1.

The most common adverse reactions reported in at least 20% of patients included upper respiratory tract infection, fatigue, pneumonia, musculoskeletal pain, and diarrhea. Common hematology abnormalities included decreased leukocytes, neutrophils, lymphocytes, platelets, and hemoglobin.

Sikander Ailawadhi, MD, principal investigator of the IRAKLIA study at Mayo Clinic Florida, noted that the OBI "offers an opportunity to impact the patient experience while upholding Sarclisa's consistent efficacy."

Sarclisa has been approved in approximately 60 countries across four indications and has been used to treat more than 70,000 patients worldwide, according to Sanofi. A regulatory submission for the CirCLIQ OBI is currently under review in Japan.

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