FDA Approves Tudriqev for Advanced Melanoma After Two Prior Rejections

The U.S. Food and Drug Administration granted accelerated approval on August 6 to Tudriqev, a genetically modified oncolytic viral therapy, in combination with nivolumab for adults with unresectable advanced cutaneous melanoma that has progressed after treatment with a PD-1 blocking antibody-based regimen. The decision, which reverses two prior rejections, provides a new treatment option for patients with limited alternatives while a confirmatory trial is underway.

The approval concludes a lengthy regulatory review for the therapy, also known as vusolimogene oderparepvec. The FDA had previously issued complete response letters in July 2025 and April 2026, citing concerns that the supporting IGNYTE trial was not an adequate and well-controlled investigation. Regulators questioned the single-arm study's design, stating it made it difficult to isolate the contribution of Tudriqev from that of the accompanying drug, nivolumab. A third application was submitted and accepted for review, leading to an advisory committee meeting on July 30, 2026. The agency's Cellular, Tissue, and Gene Therapies Advisory Committee voted 10 to 3 that the trial results were clinically meaningful, though...