FDA Approves Replimune's Tudriqev, an Engineered Oncolytic Virus, Plus Nivolumab for Anti-PD-1-Resistant Melanoma

The FDA granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma that progressed on a prior anti-PD-1-based regimen — a genetically modified oncolytic herpes simplex virus designed to replicate within tumors and stimulate anti-tumor immunity. The approval, based on the Phase 1/2 IGNYTE trial (140 patients; 24.2% objective response rate, 14.1-month median duration of response), caps a three-submission, two-rejection regulatory saga for Replimune after FDA leadership changes. As a condition of accelerated approval, Replimune must confirm clinical benefit in an ongoing Phase 3 confirmatory trial with results expected in 2027. List price is $450,000 per course of therapy before rebates and discounts.