FDA Expected to Announce Decision on Replimune's RP1 for Advanced Melanoma Following Favorable Advisory Committee Vote

The U.S. Food and Drug Administration (FDA) is expected to announce its decision today, August 2, 2026, regarding the Biologics License Application (BLA) resubmission for Replimune's RP1 (vusolimogene oderparepvec) in combination with nivolumab. This potential approval is for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy. The decision follows a favorable 10-to-3 vote by the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) on July 30, 2026, which found the efficacy results from the single-arm IGNYTE study to be evaluable and clinically meaningful.