Replimune Group to Discuss FDA CRL for RP1 in Advanced Melanoma Treatment.

Replimune Group announced a Type A meeting with the FDA to discuss the complete response letter for RP1 in combination with nivolumab for advanced melanoma. The briefing book submitted to the FDA addresses the CRL points and includes additional data analysis and phase 3 trial design comments. The meeting aims to reach a swift resolution for RP1's accelerated approval.

Replimune Group, Inc. (Nasdaq: REPL), a clinical-stage biotechnology company specializing in oncolytic immunotherapies, has scheduled a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) for its Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma. The meeting is scheduled to address the points outlined in the CRL, with the company submitting a briefing book to the FDA that includes additional data analysis and comments on the phase 3 confirmatory trial design.

The briefing book highlights prior agreements related to the patient population, criteria for PD-1 resistance, and the use of literature to support the contribution of components. It also includes an additional analysis of data from the BLA and addresses comments about the phase 3 trial design. The company aims to engage in a productive discussion with the FDA to reach a swift resolution for the accelerated approval of RP1 in advanced melanoma.

Sushil Patel, Ph.D., CEO of Replimune, stated, "We are eager to engage in a productive discussion with the FDA to reach a swift resolution for the accelerated approval of RP1 in advanced melanoma. The melanoma community, including leading physicians and patient advocacy groups, has emphasized the urgent need for access to RP1 based on the strength of the data and limited effective treatment options for this population. We remain steadfastly committed to patient access while we work with the FDA to secure regulatory approval for RP1."

RP1 (vusolimogene oderparepvec) is Replimune's lead product candidate, based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF. This combination is intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. The company's proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response.

The meeting comes as Replimune continues to work towards securing regulatory approval for RP1, with the company noting that without accelerated approval based on the current application, continuation of the RP1 program in advanced melanoma, including the phase 3 confirmatory trial, will not be viable.

[1] https://www.globenewswire.com/news-release/2025/09/02/3142613/0/en/Replimune-Announces-Type-A-Meeting-Scheduled-with-FDA.html
[2] https://www.manilatimes.net/2025/09/02/tmt-newswire/globenewswire/replimune-announces-type-a-meeting-scheduled-with-fda/2177444