US FDA Grants Approval to Replimune's Tudriqev for Advanced Melanoma

The U.S. Food and Drug Administration has granted accelerated approval to Replimune’s genetically modified herpes‑virus therapy RP1, marketed as Tudriqev, for patients with advanced melanoma whose tumors have progressed despite prior treatment. The approval follows a FDA advisory panel vote of 10‑3 and comes after two earlier rejections that cited the single‑arm IGNYTE study’s lack of a control group.

Clinical data showed tumor shrinkage or disappearance in 24.2% of patients, with a median duration of response of 14.1 months. Tudriqev is administered in combination with Bristol Myers Squibb’s immunotherapy Opdivo (nivolumab). A confirmatory late‑stage study is ongoing. Analysts estimate peak U.S. sales could reach $708 million by 2040. The drug will compete with Iovance Biotherapeutics’ Amtagvi, approved earlier in 2024.