On August 6, 2026, the U.S. Food and Drug Administration granted accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma who progressed on an anti-PD-1 antibody-based regimen. The approval is based on an objective response rate of 24.2% and a median duration of response of 14.1 months observed in the IGNYTE trial's efficacy-evaluable population of 91 patients. Continued approval remains contingent upon verification of clinical benefit in the ongoing confirmatory Phase 3 trial, IGNYTE-3. Replimune Group, Inc. operates as a commercial-stage biotechnology company pioneering novel oncolytic immunotherapies for cancer treatment.
