FDA Advisory Committee Supports RP1 Efficacy for Advanced Melanoma Ahead of Decision Date

An FDA advisory committee has voted 10-3 that the efficacy results from the IGNYTE study for RP1 (vusolimogene oderparepvec) in combination with nivolumab are evaluable and clinically meaningful for adults with advanced melanoma that has progressed after anti-PD-1 therapy. This vote comes ahead of the FDA's target action date of August 2, 2026, for the Biologics License Application (BLA) resubmission.