USFDAJul 30, 2026, 06:16 PM
Replimune's RP1 Receives Positive FDA Advisory Committee Vote
AI Summary
Replimune Group, Inc. announced that the U.S. Food and Drug Administration's (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted 10 to 3 that the efficacy results for RP1 (vusolimogene oderparepvec) are evaluable and clinically meaningful. This positive outcome pertains to the Biologics License Application (BLA) resubmission for RP1 in combination with nivolumab for advanced melanoma patients who have progressed on prior anti-PD-1 therapy. The company expressed encouragement and looks forward to continuing to work with the FDA ahead of the August 2, 2026, target action date.
Key Highlights
- FDA's CTGTAC voted 10 to 3 that RP1 efficacy results are evaluable and clinically meaningful.
- The vote concerned the Biologics License Application (BLA) resubmission for RP1.
- RP1 is in combination with nivolumab for advanced melanoma patients who progressed on prior anti-PD-1 therapy.
- The committee discussed the IGNYTE study's reliability and clinical meaningfulness of response rates.
- The FDA's target action date for the BLA resubmission is August 2, 2026.
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