Replimune Group Inc. Schedules FDA Meeting to Address CRL for RP1 in Advanced Melanoma Treatment

Reuters
09/02
<a href="https://laohu8.com/S/REPL">Replimune Group Inc.</a> Schedules FDA Meeting to Address CRL for RP1 in Advanced Melanoma Treatment

Replimune Group Inc., a clinical-stage biotechnology company focused on developing innovative oncolytic immunotherapies, has announced a scheduled Type A meeting with the U.S. Food and Drug Administration (FDA). The purpose of the meeting is to discuss the complete response letter $(CRL)$ received for the company's Biologics License Application (BLA) for RP1 in combination with nivolumab, intended for the treatment of advanced melanoma. Replimune has submitted a briefing book addressing the FDA's concerns, including prior agreements on patient population and PD-1 resistance criteria, as well as additional data analyses. The company aims to resolve these issues swiftly to secure accelerated approval for RP1, emphasizing the urgent need for new treatment options in the melanoma community. The outcome of this meeting is critical, as without accelerated approval, the continuation of the RP1 program, particularly the phase 3 confirmatory trial, may not proceed.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Replimune Group Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9521395-en) on September 02, 2025, and is solely responsible for the information contained therein.

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