Replimune’s RP-1 for melanoma wins over FDA adcom

Source Summary

Following two complete response letters in the past year, Replimune Group Inc.’s RP-1 (suvolimogene oderparepvec) for unresectable metastatic cutaneous melanoma refractory to PD-1 therapy cleared a major hurdle when the U.S. FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 that the efficacy results from the Ignyte phase II study are evaluable and clinically meaningful.