Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma

Core Insights - The FDA has accepted the Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma, granting it Priority Review with a PDUFA action date of July 22, 2025 [1][2] - The BLA is supported by data from the IGNYTE trial, which evaluated RP1 in patients with anti-PD-1 failed melanoma, and a confirmatory Phase 3 trial, IGNYTE-3, is currently ongoing [1][3] Company Overview - Replimune Group, Inc. is a clinical stage biotechnology company focused on developing novel oncolytic immunotherapies, founded in 2015 [6] - The company's lead product candidate, RP1, is based on a proprietary strain of herpes simplex virus engineered to enhance tumor killing and activate systemic anti-tumor immune responses [5][6] Industry Context - Melanoma is the fifth most common cancer in the U.S., with approximately 100,000 new cases and 8,000 deaths estimated in 2024, highlighting a significant unmet need for effective treatments [4] - Current standard treatments include immune checkpoint blockade, but about half of patients do not respond or progress after treatment, indicating a gap in available options [4]