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WeChat· 迪福润丝生物·· 2026-08-20PickScore73

FDA Grants Accelerated Approval to Replimune's Tudriqev with PD-1 Inhibitor for Advanced Melanoma

In brief

On August 6, 2026, the FDA granted accelerated approval to Replimune's oncolytic virus therapy Tudriqev in combination with a PD-1 inhibitor for patients with PD-1-resistant advanced melanoma. It is the first approved oncolytic virus combination therapy worldwide and the first oncolytic virus approval by the FDA in 11 years.

Why it matters

First FDA-approved oncolytic virus combination therapy and first oncolytic virus approval in 11 years.

Source: WeChat · mp.weixin.qq.com

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org