An FDA advisory committee voted 10-3 July 30 that efficacy results from Replimune’s study for RP1 were evaluable and clinically meaningful, advancing the company’s application for the experimental melanoma therapy after the FDA rejected it twice.
The Cellular, Tissue, and Gene Therapies Advisory Committee reviewed Replimune’s biologics license application resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma whose disease progressed after prior anti-PD-1 therapy, according to a July 30 news release.
The panel considered whether Replimune’s single-arm Ignyte study could reliably measure response rate and duration of response and whether the observed responses reflected systemic antitumor activity attributable to RP1. The committee ultimately concluded the trial’s efficacy results were clinically meaningful despite concerns raised by FDA reviewers.
The vote follows the FDA’s decision in May to allow Replimune to resubmit its application after issuing complete response letters in July 2025 and April 2026. If approved, RP1 would be used in combination with nivolumab to treat patients with advanced melanoma whose disease has progressed after anti-PD-1 therapy, a population with limited treatment options.
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