Replimune Group, Inc. announced on July 22, 2025, that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab. The BLA was for the treatment of advanced melanoma.
The CRL indicates that the FDA is unable to approve the application in its present form. The FDA stated that the IGNYTE trial is not considered an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.
Specifically, the FDA noted that the IGNYTE trial cannot be adequately interpreted due to the heterogeneity of the patient population. This decision represents a significant regulatory setback for Replimune's lead product candidate.
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