Replimune’s melanoma therapy RP1, now called Tudriqev, has received FDA accelerated approval as a combination treatment with Bristol Myers Squibb’s Opdivo for advanced melanoma patients whose disease progressed on prior anti‑PD‑1 therapy.
The approval comes after two prior rejections, both based on concerns that the single‑arm IGNYTE trial lacked a control group and provided insufficient evidence of clinical benefit.
An FDA advisory panel voted 10 to 3 that the trial data were evaluable and showed meaningful benefit, helping sway the agency despite staff reservations.
The decision marks Replimune’s first marketed product and caps a contentious saga involving clashes with former FDA leadership, White House pressure, and frequent questioning of evolving regulatory standards.
Approval is contingent on an ongoing Phase 3 confirmatory trial testing Tudriqev‑Opdivo against standard PD‑1 or chemotherapy regimens, with results expected in late 2027.
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