Replimune’s RP1 vusolimogene oderparepvec program got a lift after an FDA panel vote that supported advancing the therapy despite negative materials in the agency’s briefing package. The development keeps the company’s single-arm IGNYTE Phase I/II evidence in play for advanced melanoma patients whose tumors progressed on anti–PD-1 therapies. The BLA for RP1 in combination with nivolumab was submitted in November 2024 and had already earned designations including breakthrough therapy and priority review.