Replimune plans to ask the U.S. Food and Drug Administration (FDA) for a re-review of its advanced melanoma drug RP1 (vusolimogene oderparepvec) after the agency issued a second complete response letter rejecting the therapy in combination with nivolumab (Opdivo). The company has requested a meeting with the FDA to seek reconsideration, arguing that the clinical data show meaningful benefit in patients with unresectable, advanced cutaneous melanoma whose disease has progressed on prior PD-1 inhibitors. The FDA has stood by its position that the trial (the IGNYTE single‑arm study) is not an adequate and well‑controlled clinical investigation and that the data submitted are insufficient to demonstrate substantial evidence of effectiveness. The rejection has sparked controversy, with key trial investigators and some oncologists urging the FDA to re‑review the application.
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