Press Release: Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US

Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US

Paris, April 22, 2026. 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 (SC) in combination with approved standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all currently approved US indications of Sarclisa intravenous (IV) formulation. The revised target action date for the FDA decision is July 23, 2026.

Sanofi is committed to working closely with the FDA to bring this new advancement to patients and providers as quickly as possible. If approved, Sarclisa would be the first anticancer treatment to be administered through an on-body injector (OBI).

On March 26, 2026, the European Medicine Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Sarclisa SC administered via both an OBI and manual injection for the treatment of MM patients across all currently approved indications and combinations for Sarclisa IV formulation in the EU. A final decision is expected in the coming months.

 

About Sarclisa

Sarclisa (isatuximab-irfc) has been approved in almost 60 countries across four indications for certain patients with newly diagnosed MM and relapsed or refractory MM. Sarclisa-based regimens have been prescribed to treat more than 60,000 patients worldwide. 



At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need.



For more information on Sarclisa clinical studies, please visit .



About Sanofi 

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

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