Sarclisa (isatuximab-irfc) Approved as a Subcutaneous Injection for Multiple Myeloma by the FDA

On July 9, 2026, the U.S. FDA "approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis U.S. LLC) for subcutaneous injection for multiple myeloma indications." According to an FDA press release, those indications are the following:

• "in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor,
• in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, and
• in combination with bortezomib, lenalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for an autologous stem cell transplant."

The efficacy of the use of subcutaneous isatuximab with these indications was evaluated through the IRAKLIA (NCT05405166), IZALCO (NCT05704049), and IsaSocut (NCT05889221) clinical trials.

According to the FDA, "the recommended isatuximab-irfc dose is 1,400 mg administered as a subcutaneous injection with the CirCLIQ OBDS or with a syringe and infusion set for manual administration, in combination with the specified regimens."

"The prescribing information includes warnings and precautions for hypersensitivity and other administration reactions, neutropenia, infections, secondary primary malignancies, laboratory test interference, and embryo-fetal toxicity."

Full prescribing information for Sarclisa Escena will be posted on Drugs@FDA.

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