Replimune’s RP-1 (suvolimogene oderparepvec) moved one step closer to a potential FDA decision after an advisory committee vote endorsed the company’s efficacy readouts for unresectable metastatic cutaneous melanoma refractory to anti–PD-1 therapy. The FDA CTGTAC panel voted 10–3 that the Ignyte Phase II results were evaluable and clinically meaningful, following earlier complete response letters. Replimune is positioning RP-1 in combination with Opdivo (nivolumab), aiming to address limited outcomes for patients whose disease progresses on checkpoint inhibitors. The FDA is slated to decide on RP-1 by Aug. 2, according to the latest briefing materials and panel discussion. For investors and developers, the key issue remains how the trial—largely single-arm in design—supports survival and response interpretation in a regulatory setting that has been increasingly cautious about evidentiary strength.