BLA Accepted for Melanoma Combination Therapy, RP1 and Nivolumab

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The FDA has accepted the biologics license application (BLA) for Replimune’s RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma, according to a recent news release. This combination therapy has been given priority review with a Prescription Drug User Fee Act (PDUFA) action date of July 22, 2025.

Melanoma is currently the fifth most common skin cancer in the United States, characterized by the uncontrolled growth of melanocytes, the cells that give skin its tan or brown color and protects it from harmful UV rays. In 2025, there will be an estimated 104,960 new cases and approximately 8,430 deaths from melanoma, according to the American Cancer Society. Although melanoma accounts for only about 1% of skin cancer cases, it causes a majority of skin cancer deaths due to its tendency to metastasize. Melanoma is more common in White individuals due to the lack of melanin in their skin.

This BLA is supported by the IGNYTE trial, which evaluated the efficacy of RP1 combined with nivolumab in patients with anti-PD-1 failed melanoma, meaning the melanoma has progressed when treated with only an immune checkpoint inhibitor. IGNYTE-3, a confirmatory global phase 3 trial, is currently under way with more than 100 sites planned. It will study the effect of RP1 and nivolumab in advanced melanoma patients ineligible for anti-CTLA-4 treatment or who have progressed on anti-PD-1 and anti-CTLA-4 therapies.

RP1 is a genetically modified version of the herpes simplex virus, enhanced with a fusogenic protein (GALV-GP R-) and GM-CSF. Nivolumab is a cancer immunotherapy drug called an immune checkpoint inhibitor. After immune blockage checkpoint therapy, treatment options are limited. Researchers hope that the combination of RP1 and nivolumab will be more effective.

“There are limited treatment options and a significant unmet need for patients with advanced melanoma who previously received an anti-PD-1 containing regimen,” Sushil Patel, Ph.D., CEO of Replimune said in the news release. “The BLA acceptance is an important milestone for Replimune, and we look forward to working closely with the FDA on the review of our application.”