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# FDA Rejects Replimune BLA for Melanoma Therapy
- URL: https://www.fdaweb.com/fda-rejects-replimune-bla-for-melanoma-therapy/
- Published: 2025-07-22T12:00:00.000Z
- Updated: 2026-09-14T15:17:11.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159547

FDA has rejected a Replimune priority-reviewed BLA for its melanoma therapy RP1 (vusolimogene oderparepvec). In a just-issued complete response letter, the agency said it could not approve RP1 in combination with nivolumab due to concerns about the clinical trial data. According to Replimune, FDA found the pivotal IGNYTE trial insufficient as an “adequate and well-controlled” investigation. The agency also said the study’s heterogeneous patient population made the results difficult to interpret and pointed to unresolved issues in the design of a confirmatory trial, including questions about the contribution of each drug component.

Replimune says it plans to “urgently” request a Type A meeting with FDA, which it expects will be scheduled within 30 days, to discuss next steps. The company emphasized the importance of finding a path toward accelerated approval, warning that without it, development of RP1 for patients with advanced cancers may not be viable.

The BLA, which was filed in January, is supported by data from the IGNYTE trial demonstrating that one-third of patients treated with RP1 experienced a “confirmed response, with an overall response rate of 33.6%,” the company says. RP1’s design was based on a proprietary strain of the (XXX INSERT XXX)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.