Advisory panel backs Replimune’s RP1 for melanoma despite data questions

An FDA advisory committee voted 10-3 in favor of Replimune’s RP1 oncolytic virus (with Opdivo) for advanced melanoma, citing signs of efficacy despite significant trial-design concerns that the FDA flagged (no control arm, RECIST deviations, reinjection artifacts). While some data hint at systemic activity, the panel stressed uncertainty and noted the ongoing Ignyte-3 phase 3 data as pivotal; the FDA decision on RP1 is expected by August 2 amid a large unmet need for refractory melanoma treatments.