FDA Expected to Announce Decision on RP1 for Advanced Melanoma

The FDA has a target action date of August 2, 2026, for its decision on the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma that has progressed after anti-PD-1 therapy. An advisory committee previously voted 10 to 3 in favor of the efficacy evidence supporting the investigational oncolytic immunotherapy.