Replimune Group’s Biologics License Application for RP1 Accepted by FDA for Advanced Melanoma Treatment

Replimune Group, Inc. recently announced that its Biologics License Application (BLA) for RP1 in combination with nivolumab for patients with advanced melanoma has been accepted by the U.S. Food and Drug Administration (FDA). This development was made public in a news release issued by the company on January 21, 2025.

The FDA has granted the BLA Priority Review status with a Prescription Drug User Fee Act (PDUFA) action date set for July 22, 2025. Notably, the FDA has indicated that there are no current plans for an advisory committee meeting regarding this application, and no potential review issues have been identified at this time.

The BLA submission is supported by primary analysis data from the IGNYTE trial. This trial evaluated the effectiveness of RP1 when combined with nivolumab in patients with advanced melanoma who had not responded to previous anti-PD-1 therapy. In addition to this, a Phase 3 trial, IGNYTE-3, is currently underway with over 100 sites planned globally.

Sushil Patel, Ph.D., Chief Executive Officer of Replimune Group, expressed the significance of this milestone for the company and highlighted the critical need for treatment options for advanced melanoma patients who have exhausted anti-PD-1 containing regimens. Patel emphasized the company’s commitment to collaborating closely with the FDA throughout the application review process.

RP1, Replimune’s lead product candidate, is designed to enhance tumor killing potency and activate a systemic anti-tumor immune response. The company’s RPx platform is centered around a potent HSV-1 backbone with the goal of stimulating immunogenic cell death and inducing a systemic anti-tumor immune response.

Melanoma, the fifth most common cancer, poses a significant challenge with limited treatment options available for patients who do not respond to immune checkpoint blockade therapies. RP1 offers a promising approach to addressing this unmet medical need.

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with a focus on developing novel oncolytic immunotherapies. The company’s RPx platform aims to revolutionize cancer treatment by leveraging potent viral-based technologies.

The full details of the BLA submission and the Company’s news release can be accessed on Replimune’s website. For more information on the clinical trials and product candidates, please visit www.replimune.com.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Replimune Group’s 8K filing here.

About Replimune Group

Replimune Group, Inc, a clinical-stage biotechnology company, focuses on the development of oncolytic immunotherapies to treat cancer. The company's proprietary tumor-directed oncolytic immunotherapy product candidates are designed and intended to activate the immune system against cancer. Its lead product candidate is RP1, a selectively replicating version of HSV-1 that expresses GALV-GP R(-) and human GM-CSF, which is in Phase I/II clinical trials for a range of solid tumors; and that has completed Phase II clinical trials for treating cutaneous squamous cell carcinoma.