Replimune's twice-rejected melanoma drug, RP1 (vusolimogene oderparepvec), has prevailed in an FDA advisory committee vote for advanced melanoma, with a 10–3 decision supporting its efficacy data as evaluable and clinically meaningful; the FDA is expected to issue a decision by August 2, 2026, following two prior rejections in July 2025 and April 2026 over concerns about single‑arm trial design and insufficient evidence of systemic benefit.
RP1 is an oncolytic virus immunotherapy given in combination with nivolumab (Opdivo) for adult patients with advanced melanoma who have progressed on prior anti–PD‑1 therapy, and the FDA has agreed to prioritized review due to significant unmet need.
Despite pre‑meeting FDA concerns that trial methods may have overstated response rate and duration, and that the lack of a control group makes it difficult to isolate RP1’s contribution, the advisory committee still backed the data, leading to a surge in Replimune’s stock price and expectations that accelerated approval is now likely.
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