Replimune’s RP-1 (suvolimogene oderparepvec) took a major step forward as FDA advisers voted 10-3 in favor of the company’s melanoma efficacy case, rejecting arguments that the survival analysis was “not interpretable” and that the trial design obscured RP-1’s effect versus concurrent Opdivo. The panel deemed the efficacy results “evaluable and clinically meaningful.” The FDA decision is now due by Aug. 2, with a different outcome potentially forcing Replimune back to a confirmatory trial expected to deliver late in 2027. The resubmission follows two prior complete response letters, and FDA scientists previously challenged whether the single-arm, tumor-response-forward design could robustly support clinical benefit. In parallel, Replimune defended its trial design and results at the advisory meeting, arguing that RP-1 added benefit when combined with checkpoint inhibition for patients whose melanoma progressed after anti-PD-1 therapy. Acting FDA Center for Biologics Evaluation and Research director Karim Mikhail emphasized the unmet-need context and the agency’s urgency in evaluating potential benefit for a hard-to-treat population.