The U.S. Food and Drug Administration (FDA) on Wednesday delayed its decision on Sanofi SA’s (NASDAQ:SNY) subcutaneous Sarclisa formulation while separately broadening the eligible patient population for Tzield.

FDA Extends Sarclisa SC Review Timeline

The FDA has pushed its target action date for the biologics license application for Sarclisa (isatuximab-irfc) subcutaneous (SC) formulation by up to three months.

The agency now expects to deliver its decision by July 23.

The application covers the 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 version.

If cleared, the subcutaneous version could become the first anticancer treatment delivered via an on-body injector, offering a potentially more convenient administration method.