An FDA advisory committee voted in favor of Replimune’s experimental melanoma therapy RP-1 (suvolimogene oderparepvec), concluding that the efficacy results from the Ignyte study were evaluable and clinically meaningful. The decision raises the probability of an FDA approval by the agency’s target timeline, after the program previously received complete response letters. Adcom members rejected concerns from FDA reviewers that the survival analyses were not interpretable and that the single-arm design made it difficult to distinguish RP-1 effects from those of concurrent immune checkpoint inhibitor therapy. Replimune is seeking accelerated approval for unresectable metastatic cutaneous melanoma refractory to PD-1 treatment. Replimune has emphasized an unmet-need rationale for this patient population and argued the trial readouts support meaningful clinical benefit, a central point for the FDA’s next decision.