Replimune argues its oncolytic virus plus checkpoint inhibitor benefits advanced melanoma patients at FDA advisory meeting

Replimune presented data from its pivotal advanced melanoma trial to an FDA advisory committee.

The company defended the trial design and results, emphasizing the added benefit of its oncolytic virus when combined with a checkpoint inhibitor.

Panel members had expressed skepticism, but Replimune countered concerns about efficacy and safety.

The advisory meeting’s outcome will shape the next steps toward potential regulatory approval.