Sanofi announced that the U.S. Food and Drug Administration has extended the review period for its subcutaneous formulation of Sarclisa by up to three months, setting a new target decision date of July 23, 2026.

The application covers the use of Sarclisa SC in combination with standard treatments for multiple myeloma across all currently approved indications of its intravenous version. If approved, the therapy would become the first anticancer treatment delivered via an on-body injector, potentially improving patient convenience and administration efficiency.

Meanwhile, the European Medicines Agency has already issued a positive opinion for the subcutaneous version, with a final decision in the European Union expected in the coming months.