FDA Panel to Consider Contested Melanoma Therapy RP1

On July 30, 2026, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee was set to convene to examine Replimune’s submission for accelerated approval of vusolimogene oderparepvec (RP1; Tudriqev) in combination with nivolumab (Opdivo) for adults with advanced cutaneous melanoma that has progressed despite prior anti–PD-1 therapy. The vote comes after the FDA has already twice declined to approve the application, and the briefing documents released ahead of the meeting reveal unresolved disagreements between the agency’s review team and the sponsor over whether the underlying data from the phase 2 IGNYTE trial (NCT03767348) is sufficient to show efficacy of the combination.^1,2