FDA advisory panel backs Replimune's melanoma therapy RP1, raising approval prospects

Advisors to the U.S. Food and Drug Administration voted 10-3 in favor of Replimune's experimental melanoma treatment, RP1, despite lingering scientific concerns about the data presented.

The panel concluded that the efficacy results from the key study were evaluable and clinically meaningful, which improves the likelihood that the FDA will grant approval when it makes its decision by early August.

If the agency again rejects RP1, Replimune would need to wait for results from a confirmatory trial slated for late 2027 before filing a new application.

The therapy is aimed at patients whose melanoma has progressed after receiving standard immunotherapies such as Merck's Keytruda or Bristol Myers Squibb's Opdivo, a group that currently has few effective options.