Posted by Michael Wonder on 22 Jul 2025
Replimune receives complete response letter from FDA for RP1 biologics license application for the treatment of advanced melanoma
23 July 2025 - Replimune Group today announced that the US FDA has issued a complete response letter regarding the biologics license application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.
The complete response letter indicates that the FDA is unable to approve the application in its present form. The FDA has indicated that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.
