Replimune Group Wins FDA Advisory Committee Backing For RP1 Melanoma Therapy Ahead Of August 2 Decision

Replimune Group, Inc., a clinical-stage biotechnology company developing oncolytic immunotherapies for cancer, announced the outcome of a meeting of the U.S. Food and Drug Administration's (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee, which reviewed the company's Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab. The therapy is being evaluated for the treatment of advanced melanoma in patients whose disease has progressed after prior anti-PD-1 therapy.

During the meeting, the advisory committee reviewed whether the single-arm Phase 2 IGNYTE study was appropriately designed and conducted to provide a reliable assessment of response rate and durability of response in the proposed patient population. The committee also discussed whether the response rate and duration of response observed in the trial were clinically meaningful and demonstrated systemic antitumor activity attributable to RP1.

Following the discussion, the advisory committee voted 10 to 3 in favor of the efficacy data, concluding that the results from the IGNYTE study were both evaluable and clinically meaningful. While the committee's recommendation is non-binding, it represents an important step in the FDA's review of the therapy.

Sushil Patel, Ph.D., Chief Executive Officer of Replimune, said the company was encouraged by the committee's positive vote and appreciated the thoughtful discussion of the IGNYTE clinical data. He also thanked the patients and physicians who participated in the meeting and shared their experiences, highlighting the significant unmet need for new treatment options for patients with advanced melanoma whose disease has progressed despite prior anti-PD-1 therapy.

Replimune said it will continue working closely with the FDA as the agency completes its review of the BLA. The FDA's target action date for its decision under the Class 1 resubmission is August 2, 2026.