FDA Rejects RP1 for Advanced Melanoma, Says IGNYTE Not a ‘Well-Controlled’ Trial

Replimune receives CRL on BLA for RP1 for advanced melanoma

Replimune has announced that the FDA has issued a Complete Response Letter regarding the Biologics License Application for RP1 in combination with nivolumab for the treatment of advanced melanoma.

FDA rejects RP1 for advanced melanoma, says IGNYTE not a ‘well-controlled’ trial

The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license application for vusolimogene oderparepvec in combination with nivolumab for the treatment of advanced melanoma.According to a company press release, the letter indicates that the FDA cannot approve the application for vusolimogene oderparepvec (RP1) — the company’s lead

Replimune Receives Complete Response Letter from FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma

WOBURN, Mass., July 22, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melan…

FDA Delays Approval of Replimune’s Melanoma Therapy Despite Promising Trial Results

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results from the IGNYTE trial.

FDA Issues CRL for Vusolimogene Oderparepvec in Advanced Melanoma

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.

FDA Gives RP1 Combo Complete Response Letter in Advanced Melanoma

The FDA indicated that data from the phase 1/2 IGNYTE trial were not adequate to provide evidence of effectiveness.