Replimune receives FDA acceptance of resubmitted BLA for RP1 in advanced melanoma
- Replimune (NASDAQ:REPL) announced that the FDA accepted for review its resubmitted Biologics License Application for RP1 plus nivolumab in advanced melanoma.
- The FDA designated the filing a complete Class 1 response with a target decision date of August 2, 2026, and plans to hold an advisory committee meeting in late July.
- Replimune is seeking accelerated approval based on data from the IGNYTE trial in patients who progressed on prior anti-PD-1 therapy.
Replimune (NASDAQ:REPL) announced that the U.S. Food and Drug Administration has accepted for review the company’s resubmitted Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.
The FDA deemed the resubmission a complete, Class 1 response and assigned a target action date of August 2, 2026.
The agency also plans to hold an advisory committee meeting in late July to discuss the application.
Replimune is seeking accelerated approval for the combination based on results from the IGNYTE clinical trial in patients with advanced melanoma who had previously progressed on anti-PD-1 therapy.
RP1 is an investigational oncolytic immunotherapy designed to replicate selectively in tumor cells and drive a systemic anti-tumor immune response when combined with nivolumab.
