Dossier
PD-1-inhibitor
Coverage of PD-1-inhibitor in the Nexus archive.
- 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.