FDA Grants Accelerated Approval to Tudriqev for PD-1-Refractory Advanced Melanoma

The US Food and Drug Administration (FDA) has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma whose disease progressed on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.

The approval provides a new treatment option for patients with anti-PD-1-refractory melanoma, a population with limited therapeutic options after progression on immunotherapy. Tudriqev is the first oncolytic viral therapy approved for this indication under the FDA's accelerated approval pathway.

“For patients with advanced melanoma that has stopped responding to PD-1 blocking therapy, the prognosis is often devastating, and options have been far too limited. Clinicians managing these patients know this urgency firsthand,” said Karim Mikhail, B Pharm, MS, acting director of the FDA Center for Biologics Evaluation and Research. “Today’s important milestone gives oncologists a meaningful new tool—and more patients a fighting chance.”

Tudriqev is based on a genetically modified herpes simplex virus type 1 (HSV-1) engineered to selectively infect and destroy tumor cells while stimulating an antitumor immune response. When administered with nivolumab, the therapy is intended to help restore immune activity in patients whose melanoma no longer responds to PD-1 blockade.

The FDA approval was supported by an open-label, multiregional, single-arm clinical trial that enrolled 140 adults with stage IIIB, IIIC, or IV unresectable advanced melanoma who experienced disease progression after at least 8 consecutive weeks of prior anti-PD-1-based therapy. Among the 91 evaluable patients, 24% achieved an objective response, with a median duration of response of 14.1 months.

Tudriqev is administered by intratumoral injection every 2 weeks for 8 consecutive doses, with the initial dose given at a lower concentration followed by higher-concentration doses thereafter. Nivolumab treatment begins during week 3 and is administered intravenously.

The most common adverse reactions, reported in more than 10% of patients, included fatigue, pyrexia, infections, chills, musculoskeletal pain, nausea, diarrhea, injection-site reactions, headache, cough, influenza-like illness, rash, vomiting, pruritus, arthralgia, constipation, decreased appetite, dizziness, dyspnea, hemorrhage, edema, and abdominal pain. The prescribing information also includes warnings regarding inadvertent transmission of herpes infection, herpes infection or reactivation in treated patients, and complications related to the injection procedure.

Reference
FDA approves new engineered viral immunotherapy for patients with treatment-resistant advanced melanoma. Press release. August 6, 2026. Accessed August 7, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-new-engineered-viral-immunotherapy-patients-treatment-resistant-advanced-melanoma?utm_medium=email&utm_source=govdelivery