The FDA granted accelerated approval to Replimune’s RP1, marketed as Tudriqev, for advanced melanoma after a two-rejection saga that drew public dispute and an FDA advisory vote. The treatment is an engineered oncolytic virus given directly into tumors, used alongside Bristol Myers Squibb’s Opdivo (pembrolizumab) in patients whose disease progressed after PD-1 therapy. Regulators relied on data from a single-arm study showing roughly one quarter of patients achieved tumor response, with effects lasting a median of just over 14 months. FDA reviewers had challenged the trial design and response assessment, but an advisory panel ultimately concluded the signal supported approval in a difficult-to-treat population. The accelerated pathway makes continued approval contingent on an ongoing Phase 3 trial testing Tudriqev plus Opdivo against PD-1 drugs or chemotherapy, with results expected in late 2027. Replimune previously warned it could scrap the program if the FDA again denied the application.