CTGT Preview: Advisory Committee to Weigh Contested Melanoma Data on July 30
On July 30, the FDA will convene the Cellular, Tissue, and Gene Therapies Advisory Committee to determine whether data from the IGNYTE trial can support an accelerated approval of RP1 plus nivolumab.
On July 30, 2026, the FDA’s Cellular, Tissue, and Gene Therapies (CTGT) Advisory Committee will 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