The FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec) — an engineered virus that attacks tumors — for advanced melanoma that has stopped responding to standard immunotherapy.
Announced August 6, 2026, Tudriqev (developed by Replimune, formerly known as RP1) is approved in combination with the immunotherapy nivolumab for adults with unresectable advanced cutaneous melanoma whose disease progressed on a PD-1-blocking drug. It is a genetically modified oncolytic virus: injected directly into tumors, it infects and destroys cancer cells while also alerting the immune system to attack the cancer.
The evidence
Approval was based on a trial of 140 patients with Stage IIIB, IIIC or IV melanoma who had progressed on prior anti-PD-1 therapy. Among the 91 patients evaluated for response, 24% had an objective response, with a median duration of 14.1 months. Common side effects included fatigue, fever, infections, chills, muscle and joint pain, nausea and injection-site reactions.
A long road
The approval is notable for its history: it came after the FDA had twice rejected the therapy. As an accelerated approval, continued approval may depend on confirmatory trials verifying the benefit. Still, it adds a rare new option for patients who have run out of standard choices.