Replimune’s RP-1 won a pivotal endorsement from the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee, with panelists voting 10 to 3 that efficacy results from the Ignyte phase 2 study are evaluable and clinically meaningful. The vote raises the odds that the FDA will approve RP-1 for unresectable metastatic cutaneous melanoma after progression on anti–PD-1 therapy. The FDA’s decision is now set for Aug. 2. A negative outcome would have forced Replimune back to a confirmatory trial expected in late 2027, after the company had already received two complete response letters for the program. While the panel endorsed the trial’s interpretability, earlier FDA critiques centered on how a single-arm design made it difficult to separate RP-1 effects from checkpoint inhibitor treatment context—an issue likely to remain central to the agency’s final benefit-risk judgment.