FDA advisory panel backs Replimune’s melanoma immunotherapy combined with Opdivo

The FDA’s Cellular, Tissue and Gene Therapies advisory committee voted 10-3 to recommend Replimune’s RP1 immunotherapy, used together with Bristol Myers Squibb’s Opdivo, for patients with advanced melanoma.

Committee members praised signals of efficacy but raised concerns about the Phase 1/2 IGNYTE study’s trial design and the criteria used to assess tumor response, describing the data as “messy” and calling for clearer endpoints.

While the advisory panel’s recommendation is not binding, the FDA typically follows such advice. A final regulatory decision is expected by August 2, and approval would depend on how the agency resolves the design issues.