# FDA Accepts Replimune RP1 BLA Re-Resubmission for Advanced Melanoma; AdCom Set for Late July 2026

> fda · REPORTED · 2026-06-26

The FDA accepted Replimune's latest resubmission of the BLA for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma as a complete class 1 response, setting an August 2, 2026 PDUFA goal date and scheduling an advisory committee meeting in late July 2026. This is the drug's third shot at approval after a CRL in July 2025.

- Company: Replimune
- Sector: oncology
- Primary source: https://ir.replimune.com/news-releases/news-release-details/replimune-announces-fda-acceptance-rp1-biologics-license

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