Replimune Gains FDA Accelerated Approval for Tudriqev with Nivolumab in Unresectable Melanoma

Replimune's oncolytic viral therapy vusolimogene oderparepvec-wtpg (Tudriqev) now carries an FDA accelerated approval for use in combination with nivolumab, a designation that simultaneously opens a commercial pathway and locks the company into a confirmatory trial obligation that will define the product's long-term regulatory standing.

The August 6, 2026 approval covers adult patients with unresectable advanced cutaneous melanoma who progressed on a PD-1-blocking antibody-based regimen. Efficacy data derive from IGNYTE (NCT03767348), an open-label, single-arm trial in 140 patients, of whom 91 with at least one noninjected lesion formed the efficacy-evaluable population. The primary endpoints, objective response rate and duration of response, returned an ORR of 24.2% (95% CI: 15.8, 34.3) and a median DOR of 14.1 months (10.7, not reached). Accelerated approval on surrogate endpoints means continued market access remains contingent on verification of clinical benefit in post-approval confirmatory trials.

For QA and manufacturing leads, the regulatory classification warrants close attention. Tudriqev is a genetically modified oncolytic virus, placing its manufacture squarely within cell and gene therapy (CGT) frameworks, including the heightened sterility assurance, viral clearance validation, and lot-release testing expectations that accompany biologics of this complexity. The FDA convened its Cellular, Tissue, and Gene Therapies Advisory Committee on July 30, 2026, one week before approval, with deliberations covering patient testimony, clinician input, and independent expert review. The advisory committee's engagement signals that the agency is applying CGT-level scrutiny to oncolytic viral products, a precedent manufacturing teams at comparable sponsors should factor into process validation planning.

Dosing logistics add an operational layer that clinical and pharmacy teams will need to manage precisely. The recommended intratumoral dose is 1 mL per centimeter of the largest tumor dimension, capped at 10 mL across all treated lesions per visit. Injections run every two weeks for eight consecutive doses, starting at 10⁶ PFU/mL at Week 1 and escalating to 10⁷ PFU/mL thereafter. Nivolumab is introduced intravenously at Week 3 per its existing prescribing information. The prescribing information carries warnings for accidental exposure, herpetic infection or reactivation, injection procedure complications, and immune-mediated events, each of which has implications for site training, handling SOPs, and adverse event reporting under 21 CFR Part 211 and MedWatch obligations.

Tudriqev also holds breakthrough therapy designation, reflecting the agency's earlier assessment of preliminary clinical evidence in this heavily pretreated population.

The confirmatory trial timeline Replimune submits to the FDA will be the next measurable checkpoint for determining whether accelerated approval converts to full approval.

Source: FDA Drugs@FDA / What's New: Drugs RSS Feed, August 6, 2026.