Replimune Group, Inc. announced on January 21, 2025, that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec). The BLA is for RP1 in combination with nivolumab for the treatment of patients with advanced melanoma.
The FDA granted the BLA Priority Review, a designation for drugs that, if approved, would provide significant improvements in the safety or effectiveness of treating serious conditions. This accelerates the review timeline for RP1.
A PDUFA (Prescription Drug User Fee Act) action date has been set for July 22, 2025. This acceptance and priority review mark a significant step towards potential regulatory approval and commercialization of RP1.
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