STAT+: FDA staff reiterate concerns about Replimune skin cancer treatment

FDA staff have reiterated concerns about insufficient data to support approval of Replimune’s investigational skin cancer treatment RP1. The agency criticized a single-arm trial combining RP1 with Opdivo, arguing it fails to establish the drug’s efficacy or systemic benefits, while Replimune claims ethical and feasibility challenges prevent a placebo-controlled study.