French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Wednesday that the US Food and Drug Administration (FDA) has extended by up to three months the target action date for its review of the Biologics License Application for Sarclisa (isatuximab-irfc) subcutaneous formulation.

The new FDA decision date is 23 July 2026.

The application covers use in combination with approved standard-of-care regimens for multiple myeloma across all current US indications of the intravenous formulation. If approved, Sarclisa would become the first anti-cancer therapy administered via an on-body injector.

Sanofi said that it continues to work with the FDA to advance availability of the treatment for patients and healthcare providers. The company highlighted the potential for the subcutaneous formulation to expand administration options.

In Europe, the Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of the subcutaneous version delivered via on-body injector or manual injection. A final European decision is expected in the coming months.

Sarclisa is currently approved in nearly 60 countries across four indications for newly diagnosed and relapsed or refractory multiple myeloma, with more than 60,000 patients treated worldwide.