FDA approves Tudriqev, engineered viral therapy for PD-1–resistant melanoma

FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma that has progressed on a programmed death receptor-1 (PD-1)–blocking antibody regimen.

The approval addresses a difficult treatment setting: many patients with advanced melanoma eventually progress despite checkpoint immunotherapy, leaving fewer effective options. Tudriqev takes a different approach by injecting an engineered virus directly into tumors to kill cancer cells and stimulate an immune response that may help restore sensitivity to PD-1 blockade.

Tudriqev is a genetically modified herpes simplex virus type 1 designed to preferentially replicate within tumors. As infected cancer cells break apart, they release tumor antigens and inflammatory signals that can help recruit immune cells. The virus is also engineered to enhance tumor-cell killing and immune activation. Used with nivolumab, the goal is to generate an antitumor response even after prior PD-1 therapy has stopped working.

Unlike treatments limited to superficial lesions, Tudriqev can be injected into superficial tumors as well as deep or visceral lesions using image guidance. It is administered intratumorally every 2 weeks for 8 doses, with nivolumab beginning at week 3.

Accelerated approval was based on the open-label IGNYTE trial. Among 91 efficacy-evaluable patients with at least one noninjected lesion, 24% achieved an objective response, with responses lasting a median 14.1 months.

Important safety concerns include accidental exposure to the modified virus, herpes infection or reactivation, and complications from injecting visceral lesions. Common adverse reactions included fatigue, fever, chills, musculoskeletal pain, gastrointestinal symptoms, injection-site reactions, and influenza-like illness.

Because approval was based on response rate and durability rather than demonstrated survival benefit, continued approval depends on confirmation of clinical benefit. The phase 3 IGNYTE-3 trial is ongoing.

“Advanced melanoma patients have few options after anti-PD-1 therapy and face high morbidity and poor survival outcomes,” said Michael K. Wong, MD, PhD, primary investigator of IGNYTE and former physician in chief and professor of oncology at Roswell Park Comprehensive Cancer Center. “With the approval of Tudriqev, we have a potent oncolytic immunotherapy that can be used in a broad population, including BRAF-naïve or pretreated, and adjuvant relapsed patients.”

Source: FDA. (2026 Aug 6). FDA approves new engineered viral immunotherapy for patients with treatment-resistant advanced melanoma