USFDAJun 26, 2026, 08:02 AM
Replimune FDA Accepts RP1 BLA Resubmission for Advanced Melanoma
AI Summary
Replimune Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec). This application is for RP1 in combination with nivolumab for the treatment of advanced melanoma. The FDA has set a goal date of August 2, 2026, and expects an advisory committee meeting in late July to discuss the accelerated approval sought based on data from the IGNYTE clinical trial.
Key Highlights
- FDA accepted the Biologics License Application (BLA) resubmission for RP1.
- RP1 is in combination with nivolumab for advanced melanoma treatment.
- FDA set a goal date of August 2, 2026, for the BLA decision.
- An advisory committee meeting is expected in late July.
- The resubmission seeks accelerated approval based on IGNYTE clinical trial data.
- Advanced melanoma is estimated to have 112,000 new cases in 2026.
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