Replimune Group Inc. announced that the U.S. Food and Drug Administration (FDA) has officially accepted its resubmitted Biologics License Application (BLA) for the investigational therapy RP1 for the treatment of advanced melanoma.

This acceptance marks a critical step for the company in advancing the marketing process of this oncolytic virus immunotherapy. The FDA has set the Prescription Drug User Fee Act (PDUFA) target review date as December 25, 2024. The submission of this BLA is primarily based on key CERPASS clinical trial data, which evaluated the efficacy and safety of combining RP1 with the anti-PD-1 therapy librolizumab compared to using librolizumab alone in patients with advanced melanoma.