The FDA has expressed ongoing concerns regarding Replimune’s efforts to gain approval for its investigational skin cancer treatment, RP1, marking the company’s third attempt. In recent briefing documents, the agency criticized Replimune’s reliance on data from a single-arm trial involving patients who had previously tried PD-1 inhibitors. The FDA argues that this study does not adequately evaluate the drug’s efficacy, while Replimune defends its approach by stating that a randomized study in this context would be impractical and unethical.
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Link to original article source: https://www.statnews.com/2026/07/28/replimune-rp1-skin-cancer-fda-staff-analysis/
