Replimune Group, Inc. announced on September 18, 2025, that it completed a Type A meeting with the U.S. Food and Drug Administration (FDA) on September 16th. The meeting was held to discuss the complete response letter (CRL) for the company’s Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma.
The company is currently evaluating the feedback received from the FDA during the meeting to determine its next steps. At this time, a path forward under the accelerated approval pathway for RP1 has not been determined.
CEO Sushil Patel reiterated Replimune's commitment to working with the FDA to determine an expeditious path forward for RP1, emphasizing the unmet need in advanced melanoma and the compelling risk-benefit profile observed in the IGNYTE trial.
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