Did FDA approve Replimune Tudriqev for PD-1 progressed melanoma patients?

Yes. On August 6, 2026, FDA granted accelerated approval to Replimune’s Tudriqev (vusolimogene oderparepvec-wtpg) with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease progressed on a PD-1-blocking regimen. The approval was based on IGNYTE trial response data and requires confirmatory post-approval studies.