# Sector Highlight — Oncology: FDA Approves First Oncolytic Viral Therapy for Anti-PD-1-Refractory Melanoma

> fda · REPORTED · 2026-08-06

Replimune's Tudriqev received FDA accelerated approval on August 6, 2026, becoming the first oncolytic viral therapy approved for advanced melanoma patients who have progressed on PD-1 checkpoint inhibitors, offering a response rate of 24.2% with durable responses after two prior rejections.

About Replimune Group, Inc.: Replimune is an oncology biotech specializing in genetically engineered oncolytic viral immunotherapies for refractory solid tumors.

- Company: Replimune Group, Inc.
- Sector: oncology
- Primary source: https://www.fda.gov/news-events/press-announcements/fda-approves-new-engineered-viral-immunotherapy-patients-treatment-resistant-advanced-melanoma

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