# FDA Issues Complete Response Letter for Replimune RP1 BLA in Advanced Melanoma

> fda · REPORTED · 2025-07-22

The FDA issued a Complete Response Letter for Replimune's BLA for RP1 plus nivolumab in advanced melanoma on July 22, 2025, stating the IGNYTE trial was not an adequate and well-controlled investigation and could not be interpreted due to patient population heterogeneity. No safety concerns were raised.

- Company: Replimune
- Sector: oncology
- Primary source: https://ir.replimune.com/news-releases/news-release-details/replimune-receives-complete-response-letter-fda-rp1-biologics

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.