Posted by Michael Wonder on 02 Aug 2025
Update on US regulatory review of supplemental biologics license application
1 August 2025 - The US FDA issued a complete response letter for the supplemental biologics license application for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in a quadruplet regimen in newly diagnosed, transplant-ineligible multiple myeloma (Phase 3 CEPHEUS study).
The complete response letetr is based on observations from facility inspections and is not related to the robust safety and efficacy data submitted for this application.
