# FDA Grants Accelerated Approval to Replimune Oncolytic Therapy Tudriqev for Advanced Melanoma

> fda · REPORTED · 2026-08-06

On August 6, 2026, the FDA granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev), Replimune's genetically modified oncolytic viral therapy, in combination with nivolumab, for adult patients with unresectable advanced cutaneous melanoma who progressed on a PD-1 blocking antibody regimen. This approval came after two prior complete response letters from the FDA in 2025 and April 2026.

About Replimune Group, Inc.: Replimune Group is a clinical-stage biotechnology company developing oncolytic immunotherapies based on a proprietary HSV platform designed to activate the immune system against solid tumors.

- Company: Replimune Group, Inc.
- Sector: oncology
- Primary source: https://www.ons.org/publications-research/voice/topics/us-food-and-drug-administration-fda

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