The U.S. Food and Drug Administration has extended its review of subcutaneous Sarclisa for multiple myeloma, with a new decision date set for July 23, 2026, while EU regulators move toward approval.
Written By: Sana Khan BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration has extended the review timeline for the subcutaneous (SC) formulation of Sarclisa by up to three months, setting a revised target action date of July 23, 2026.
The application seeks approval for use of Sarclisa SC in combination with standard-of-care regimens for patients with multiple myeloma across all currently approved U.S. indications of the intravenous (IV) formulation.
The therapy is being developed by Sanofi, which stated it is continuing to work closely with the FDA to advance the application.
If approved, the SC formulation could become the first anticancer therapy delivered via an on-body injector (OBI), offering an alternative to traditional infusion-based administration.
Regulatory progress is also underway in Europe. On March 26, 2026, the European Medicines Agency Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of Sarclisa SC for patients with multiple myeloma.
The recommendation covers administration via both an on-body injector and manual injection, aligned with all currently approved indications and combinations for the IV formulation in the European Union.
A final decision from the European Commission is expected in the coming months.
Sarclisa (isatuximab-irfc) is currently approved in nearly 60 countries across four indications, including use in patients with newly diagnosed and relapsed or refractory multiple myeloma. According to Sanofi, more than 60,000 patients worldwide have been treated with Sarclisa-based regimens.
The company emphasized its continued focus on oncology research, highlighting efforts to develop immunological and targeted therapies for cancers with high unmet need, including rare and difficult-to-treat malignancies.
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About the Writer
Sana Jamil Khan is a B.Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.