Replimune’s twice-rejected melanoma candidate RP-1 cleared an FDA advisory committee hurdle after panelists voted 10–3 that the Ignyte phase II efficacy results were evaluable and clinically meaningful. The committee’s decision increases the odds the FDA will approve RP-1 after prior complete response letters twice derailed the program. The resubmission comes with ongoing debate over how much benefit the single-arm, no-control design can establish when RP-1 is combined with Opdivo (nivolumab). Replimune executives and FDA scientists challenged the interpretability of survival analyses and how the trial handled response assessment. The FDA is expected to make a decision by Aug. 2, with a panel-driven pathway now in place following the adcom endorsement, setting up a high-stakes regulatory finish for a setting with limited options after PD-1 failure.