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# Replimune BLA for Melanoma Gets Priority Review
- URL: https://www.fdaweb.com/replimune-bla-for-melanoma-gets-priority-review/
- Published: 2025-01-21T12:00:00.000Z
- Updated: 2026-09-14T14:51:17.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158520

FDA has accepted for priority review a Replimune Group BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma. The agency has set a user fee review action target date of 7/22.

The BLA is supported by data from the IGNYTE trial demonstrating that one-third of patients treating with RP1 experienced a “confirmed response, with an overall response rate of 33.6%,” the company says. Approval is being sought under the accelerated approval pathway and a confirmatory Phase 3 trial is currently underway, it says.

RP1’s design was based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and a granulocyte-macrophage colony-stimulating factor, which is a white blood cell growth factor that plays a role in the immune system, according to the company. The therapy is intended to “maximize tumor-killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response,” it says.