USFDAJul 31, 2026, 06:08 AM
Replimune: FDA Advisory Committee votes 10-3 for RP1 efficacy
AI Summary
Replimune Group, Inc. announced that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 10 to 3 that the efficacy results from the IGNYTE study for RP1 are evaluable and clinically meaningful. This favorable outcome supports the Biologics License Application (BLA) resubmission for RP1 in combination with nivolumab for advanced melanoma. The company expressed encouragement and looks forward to the FDA's target action date of August 2, 2026.
Key Highlights
- FDA Advisory Committee voted 10 to 3 that RP1 efficacy results are evaluable.
- Committee confirmed efficacy results from the IGNYTE study are clinically meaningful.
- The vote pertains to the Biologics License Application (BLA) resubmission for RP1.
- RP1 (vusolimogene oderparepvec) is for advanced melanoma in combination with nivolumab.
- The FDA's target action date for the BLA resubmission is August 2, 2026.
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