The FDA granted accelerated approval to Replimune’s oncolytic viral therapy Tudriqev (formerly RP1) for advanced melanoma, ending a two-rejection regulatory saga that included advisory committee scrutiny. The decision clears the treatment for use in combination with Bristol Myers Squibb’s Opdivo (nivolumab) after progression on PD-1–blocking immunotherapies. Replimune’s approval follows an advisory committee vote in which FDA reviewers had challenged aspects of trial design and response interpretation, but outside panelists concluded the efficacy signal was strong enough for a heavily pretreated population. The accelerated pathway makes continued approval contingent on confirmatory evidence. The confirmatory Phase 3 program is designed to test Tudriqev-Opdivo versus PD-1–targeted therapy or chemotherapy, with readouts expected in late 2027. Replimune had warned it could halt development if the FDA again refused the application.