FDA approved Replimune’s oncolytic viral therapy Tudriqev (RP1) for advanced melanoma after a contentious path that included two prior rejections and last week’s advisory committee vote supporting the regimen. The accelerated approval covers Tudriqev in combination with Bristol Myers Squibb’s Opdivo (nivolumab) for patients whose melanoma progressed after PD-1 therapy. Regulators cleared the treatment based on a single-arm signal showing about one quarter of patients achieved some level of tumor response, with effects lasting a median of just over 14 months. FDA reviewers had raised concerns about trial design and response assessment but the advisory panel backed approval given the urgency of the patient population. Replimune previously warned that the program could be scrapped if the FDA again rejected the therapy. The confirmatory Phase 3 trial is expected to read out in late 2027 and will be required to validate benefit under the accelerated pathway.