Repligen’s oncolytic virus therapy vusolimogene oderparepvec (RP1, marketed through Replimune) cleared a key hurdle as the FDA’s ODAC/CTGTAC panel supported an accelerated-approval pathway in unresectable advanced cutaneous melanoma. On July 30, the Cellular, Tissue, and Gene Therapies Advisory Committee determined results from the IGNYTE study were evaluable and clinically meaningful in a 10–3 vote. The favorable decision comes after the FDA declined approval earlier in April. The committee vote is not binding, but FDA typically follows advisory input, especially where confirmatory evidence gaps exist. In IGNYTE’s phase 2 portion, RP1 plus nivolumab produced an objective response rate of 33.6% (95% CI 25.8–42.0) with a median duration of response of 24.8 months; excluding patients where RECIST evaluation rules conflicted with injected lesions reduced ORR to 15.7%. Committee members emphasized uncertainty in response-rate interpretation ahead of any FDA action.