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FDA Rejects Accelerated Approval of RP1 with Nivolumab for Melanoma

Jul 22, 2025

On 22 July 2025, Replimune announced that the FDA has advised it is unable to approve, in its present form, the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with BMS’ Opdivo® (nivolumab) for the treatment of advanced melanoma. The FDA considers that the clinical trial relied on is not an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. The FDA also said the trial cannot be adequately interpreted due to the heterogeneity of the patient population. However, no safety issues were raised.

Replimune submitted the BLA in November 2024 under the FDA’s Accelerated Approval pathway. The company says that the FDA’s issues were not raised during the mid- and late-cycle reviews, and that they had aligned on the design of the study, but will continue engage with the FDA to find a path forward for approval.