FDA Advisory Committee Backs RP1 Plus Nivolumab for Advanced Melanoma in 10-3 Vote

Clinical Summary: 

• Design/Population: The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee reviewed the Biologics License Application resubmission for RP1 (vusolimogene oderparepvec) plus nivolumab for patients with advanced melanoma whose disease progressed following prior anti–PD-1 therapy. The committee evaluated efficacy findings from the single-arm phase 2 IGNYTE trial.
• Key Outcomes: Following discussion of the IGNYTE data, the advisory committee voted 10 to 3 that the study's efficacy results were evaluable and clinically meaningful, supporting the reported response rate and duration of response in the proposed patient population.
• Clinical Relevance: Although advisory committee recommendations are nonbinding, the favorable vote represents an important regulatory milestone as the FDA continues its review of the BLA ahead of the August 2, 2026, target action date.

The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 10 to 3 in favor of the efficacy evidence supporting the investigational oncolytic immunotherapy RP1 (vusolimogene oderparepvec) plus nivolumab for patients with advanced melanoma whose disease has progressed following anti–PD-1 therapy, providing a positive recommendation ahead of the FDA's upcoming regulatory decision.

During the July 30 meeting, committee members examined whether the design and conduct of the single-arm phase 2 IGNYTE trial generated sufficiently reliable evidence to assess objective response rate and duration of response in the proposed indication. The panel also discussed whether the magnitude and durability of responses reflected a clinically meaningful treatment benefit and supported evidence of systemic antitumor activity beyond the injected lesions. Following deliberations, the committee concluded by a 10-to-3 vote that the study's efficacy findings were evaluable and clinically meaningful.

"We are encouraged by today's outcome and would like to thank the committee for its thoughtful discussion of the IGNYTE data," stated Sushil Patel, PhD, chief executive officer of Replimune. "We are grateful to the patients and physicians who took the time to speak today and so clearly articulate the high unmet need in advanced melanoma and importance of new treatment options such as RP1 for the community."

RP1 is an investigational oncolytic immunotherapy derived from a proprietary herpes simplex virus strain that has been genetically engineered to express granulocyte-macrophage colony-stimulating factor (GM-CSF) and a fusogenic protein (GALV-GP R-). The therapy is designed to promote direct tumor cell destruction while enhancing antitumor immune responses.

The FDA is reviewing the Biologics License Application under a Class 1 resubmission, with a target action date of August 2, 2026.

Source: 

Replimune. Replimune announces favorable outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee meeting for RP1 in advanced melanoma. Accessed on July 31, 2026. https://ir.replimune.com/news-releases/news-release-details/replimune-announces-favorable-outcome-fdas-cellular-tissue-and