Replimune’s RP-1 won support from an FDA advisory committee after the therapy had previously been rejected twice, with panelists concluding the efficacy evidence was evaluable and clinically meaningful. The vote heightens the chance the FDA will approve RP-1 for unresectable metastatic cutaneous melanoma in patients whose disease progressed on or after anti–PD-1 therapy. The agency is scheduled to decide by Aug. 2. Replimune is seeking to position RP-1 in combination with Opdivo to address a population with limited response rates, while FDA career scientists previously criticized how responses and survival analyses were interpreted in the single-arm design. The advisory recommendation comes after a contentious resubmission in which Replimune defended the trial design and the survival comparisons used to support clinical benefit, setting up a decisive regulatory outcome for the program.