FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma

On August 6, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy, for use in combination with nivolumab in adult patients with unresectable advanced cutaneous melanoma who have experienced disease progression on a PD-1-blocking antibody-based regimen. This approval addresses an urgent need in a refractory patient population with limited options and a poor prognosis.

Tudriqev is based on a modified herpes simplex virus type 1 (HSV-1) engineered to selectively target and destroy cancer cells. Once inside a tumor, the virus replicates and breaks the cancer cells apart while simultaneously triggering the body's immune system to recognize and attack the cancer. When combined with nivolumab, an anti-PD-1 immunotherapy, it may help restore an anti-tumor immune response in patients whose cancer had stopped responding to immunotherapy. The treatment is injected directly into tumors once every two weeks for eight consecutive doses, with a lower concentration for the first dose and a higher concentration for all remaining doses. Nivolumab is given intravenously beginning at week three of treatment.

The approval was supported by clinical trial data showing that one in four patients responded to treatment, with responses lasting a median of nearly 14 months. The FDA also considered input from clinical experts and patient advocates who emphasized the urgent need for effective options in this population. Acting CBER Director Karim Mikhail called the approval a "meaningful new tool" giving patients "a fighting chance," while Acting Deputy Director Megha Kaushal noted that the decision is "grounded in early evidence and backed by the accountability that accelerated approval demands."