The U.S. Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev), developed by Replimune, Inc. (NASDAQ: REPL), in combination with nivolumab for adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a PD-1-blocking antibody-based regimen.

The approval, granted on August 6, 2026, was based on objective response rate and duration of response under the FDA's accelerated approval pathway. Replimune is required to conduct post-approval trials to verify the clinical benefit of the combination therapy, and continued approval may be contingent on confirmatory trial results.

Safety and efficacy data came from the IGNYTE trial (NCT03767348), an open-label, single-arm study enrolling 140 adult patients with Stage IIIB, IIIC, or IV unresectable advanced melanoma. Of those, 91 patients with at least one noninjected lesion formed the efficacy-evaluable population. The objective response rate was 24.2%, and the median duration of response was 14.1 months.

Common adverse reactions reported in more than 10% of patients included fatigue, pyrexia, infections, chills, musculoskeletal pain, nausea, and diarrhea, among others. The prescribing information includes warnings for accidental exposure, herpetic infection or reactivation, injection procedure complications, and immune-mediated events.

The recommended dosage is 1 mL per centimeter of the largest tumor dimension, with a maximum of 10 mL across all lesions per dose, administered via intratumoral injection every two weeks for eight consecutive doses. Nivolumab is to be administered intravenously beginning at Week 3.

The FDA convened its Cellular, Tissue, and Gene Therapies Advisory Committee on July 30, 2026, to discuss the application. Tudriqev had previously received breakthrough therapy designation from the FDA.