# FDA Grants Accelerated Approval to Tudriqev Plus Nivolumab for Advanced Refractory Melanoma

> fda · REPORTED · 2026-08-06

On August 6, 2026, the FDA granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma who progressed on prior anti-PD-1 therapy, supported by a 24.2% objective response rate and 14.1-month median duration of response in the IGNYTE trial. The approval followed two prior complete response letters and a 10-3 advisory committee vote on July 30, 2026.

About Replimune Group, Inc.: Replimune is a clinical-stage oncology company developing genetically modified oncolytic viral immunotherapies designed to treat advanced solid tumors, particularly melanoma.

- Company: Replimune Group, Inc.
- Sector: oncology
- Primary source: https://ir.replimune.com/news-releases/news-release-details/replimune-announces-fda-accelerated-approval-tudriqevtm

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