FDA Panel Weighs Accelerated Approval for Replimune’s RP1 in Advanced Melanoma

The FDA’s Oncologic Drugs Advisory Committee voted 10-yes to 3-no on Replimune’s experimental therapy RP1, a combination with Bristol Myers Squibb’s Opdivo, for patients with advanced melanoma whose tumors progressed after prior treatment. The panel’s recommendation is non-binding, but the agency typically considers the advisers’ views before issuing a final ruling, which is scheduled for August 2.

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The agency declined to grant approval for RP1 twice, most recently in April, citing reliance on a single-arm study that lacked a control group. FDA reviewers said the trial’s design makes it difficult to determine whether observed tumor shrinkage was driven by RP1 and warned that the reported response rate may be inflated. Replimune is seeking accelerated approval, arguing that RP1 offers a safer, less invasive option compared with the only other FDA-approved therapy for this population, Iovance’s Amtagvi, which requires patients to be fit enough for surgery.

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• Advisory Committee vote: 10 members in favor, 3 opposed.

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• Several supportive voters expressed reservations; one described the data as “really messy.”

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• The FDA’s own analysis highlighted the absence of a control arm and potential overstatement of response rates.

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Emory University oncologist Melinda Yushak noted that the patient group is “very hard to treat” and that those receiving RP1 showed complete responses, indicating benefit. Hospital for Special Surgery’s John Carrino acknowledged a “signal” in the data despite borderline confidence, urging continued observation. Replimune chief executive Sushil Patel said the company looks forward to working with the FDA as the review concludes.

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• “This is a very hard to treat patient population... these patients then got RP1 and had some CRs (complete responses)... data does show... these patients are getting benefit from RP1,” — Melinda Yushak, a medical oncologist at Emory University

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• “I voted yes with borderline no and really aligned with those other folks who are that on that level... there is some signal (in the data) and we should follow that signal,” — John Carrino, vice chairman, department of radiology and imaging at Hospital for Special Surgery

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• “We look forward to continuing to work with the FDA as it completes its review,” — Replimune CEO Sushil Patel, said replimune CEO

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