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# Replimune BLA Resubmission for Melanoma Therapy
- URL: https://www.fdaweb.com/replimune-bla-resubmission-for-melanoma-therapy/
- Published: 2025-10-20T12:00:00.000Z
- Updated: 2026-09-14T15:24:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160064

FDA has accepted for review a Replimune BLA resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating advanced melanoma in patients whose disease has progressed on an anti–PD-1-based regimen. The agency set a user fee review action target date of 4/10.

The company says the filing includes additional information, data, and analyses to address FDA’s concerns that were raised in an July [complete response letter](https://download.open.fda.gov/crl/CRL%5FBLA125827%5F20250721.pdf?ref=fdaweb.com). The letter took issue with Replimune’s supporting clinical trial data, trial design, and the heterogeneous patient population in the Phase 1-2 IGNYTE trial. Issues were also raised about the design of the confirmatory Phase 3 IGNYTE-3 trial, specifically questioning the ability to distinguish the individual benefits of RP1 and nivolumab, according to the company.

RP1 is Replimune’s lead oncolytic immunotherapy candidate. The therapy is based on a genetically modified herpes simplex virus engineered to enhance tumor cell destruction and stimulate a systemic anti-tumor immune response, the company says. It includes genetic modifications for a fusogenic protein and GM-CSF to boost both direct tumor killing and immune activation, it says.

If approved, RP1 in combination with nivolumab could represent a new treatment option for patients with advanced melanoma who have limited therapeutic alternatives following PD-1 inhibitor therapy.