Posted by Michael Wonder on 22 Apr 2026
Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US
22 April 2026 - The US 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 in combination with approved standard of care regimens for the treatment of patients with multiple myeloma across all currently approved US indications of Sarclisa intravenous formulation.
The revised target action date for the FDA decision is 23 July 2026.
