RP1 wins favorable 10-3 AdComm vote in advanced melanoma
- Sponsor
- Replimune Group $REPL
- Drug
- vusolimogene oderparepvec
- Indication
- advanced melanoma after prior anti-PD-1 therapy
FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted 10-3 on July 30, 2026 that the efficacy results from Replimune's IGNYTE study of RP1 (vusolimogene oderparepvec) in combination with nivolumab are evaluable and clinically meaningful for patients with advanced melanoma who have progressed on prior anti-PD-1 therapy. The favorable panel vote clears the review-level hurdle FDA had cited across the two prior CRL cycles (July 2025 and April 2026). The PDUFA target action date for the third-cycle resubmission is August 2, 2026 — three business days after the AdComm.
What this means
An FDA advisory panel voted 10 to 3 that the trial data supporting Replimune's RP1 cancer drug (used with nivolumab) show a real, clinically meaningful benefit for patients with advanced melanoma who have stopped responding to prior immunotherapy. RP1 is a modified herpes virus that infects and destroys tumor cells while also alerting the immune system. FDA had rejected the drug twice before, both times citing concerns about the trial's design. This third-cycle review reaches a decision date on August 2, 2026 — just three business days after the panel vote.