Sanofi: FDA Delays Decision on Subcutaneous Sarclisa by Three Months
Sanofi announced that the American Food and Drug Administration has extended the review period for its approval application for Sarclisa in a subcutaneous formulation by three months. The new target date for the decision is set for July 23, 2026.
Extended FDA Review Period
The FDA has delayed its target action date by three months for the review of the biologics license application for Sarclisa (isatuximab-irfc) in a subcutaneous formulation. This treatment is considered in combination with approved standard therapeutic regimens for the treatment of patients with multiple myeloma in all current U.S. indications of the intravenous formulation of Sarclisa. The revised target action date for the FDA's decision is July 23, 2026. Sanofi states it is committed to working closely with the U.S. authority to bring this new advancement to patients and healthcare professionals as quickly as possible. If approved, Sarclisa would be the first cancer treatment to be administered via a portable injector.
Positive Opinion from European Medicines Agency
The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion on March 26, 2026, recommending the approval of Sarclisa in a subcutaneous formulation, administrable both through a portable injector and manual injection for the treatment of patients with multiple myeloma in all indications and combinations currently approved for the intravenous formulation in the European Union. A final decision is expected in the coming months.
