The US Food and Drug Administration has extended the target action date for its review of the biologics license application for the subcutaneous (SC) formulation of Sarclisa by up to three months. The revised decision date is now set for July 23, 2026.

The application, submitted by Sanofi, seeks approval for the use of Sarclisa SC in combination with standard-of-care regimens for the treatment of patients with Multiple Myeloma across all currently approved indications of the intravenous (IV) formulation.

If approved, the SC version of Sarclisa could become the first anticancer therapy delivered via an on-body injector (OBI), offering a potentially more convenient administration method for patients and healthcare providers.

In parallel, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in March 2026 recommending approval of Sarclisa SC in Europe. The recommendation includes administration via both an on-body injector and manual injection, with a final decision expected in the coming months.

Sarclisa is currently approved in nearly 60 countries for multiple indications in patients with newly diagnosed and relapsed or refractory multiple myeloma. To date, Sarclisa-based regimens have been used to treat more than 60,000 patients worldwide.

Sanofi stated that it is working closely with regulators to bring the new formulation to market, as part of its broader strategy to advance innovative oncology therapies for difficult-to-treat cancers.