Replimune’s RP-1 regained traction with an FDA advisory panel vote after earlier setbacks. Advisers voted 10-3 in favor of the experimental melanoma treatment’s effectiveness, concluding that the efficacy results were evaluable and clinically meaningful. The vote sets up an FDA decision date of Aug. 2, with a second rejection forcing Replimune back to confirmatory trial timelines. The discussion at the advisory meeting focused on how evidence was interpreted from a pivotal advanced melanoma study used for the resubmission, including concerns about single-arm design and survival analysis interpretability. Still, panelists found the reported outcomes sufficient to move forward in the accelerated-approval pathway. For melanoma developers, the key message is that the panel signaled acceptable evidentiary framing even amid methodological critiques. The FDA’s next decision will determine whether RP-1 can convert advisory support into an approval for patients progressing after checkpoint inhibitors.