FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma
Approval Offers New Hope for Patients with Anti-PD-1 Refractory Melanoma
Silver Spring, MD / CRWE PRESS RELEASE / August 6, 2026 - The U.S. Food and Drug Administration today granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy for the treatment of advanced, refractory melanoma. Tudriqev is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.
The approval is supported by data from a clinical trial showing that one in four patients responded to treatment, with responses lasting a median of nearly 14 months, offering clinicians a meaningful new tool for a patient population. In reaching this decision, the FDA also considered input from clinical experts and patient advocates who emphasized the urgent need for effective options in this refractory population.
“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., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER). “Today’s important milestone gives oncologists a meaningful new tool — and more patients a fighting chance.”
Anti-PD-1 refractory melanoma is advanced skin cancer that no longer responds to a widely used class of immunotherapy drugs. Despite treatment, the cancer may continue to grow because of developed mechanisms to evade the immune system’s ability to detect and destroy it.
Tudriqev is an oncolytic viral therapy based on a modified herpes simplex virus type 1 (HSV-1) that is engineered to selectively target and destroy cancer cells. Once inside a tumor, the virus replicates and breaks cancer cells apart, while simultaneously triggering the body’s immune system to recognize and attack the cancer. When used in combination with nivolumab, an anti-PD-1 immunotherapy, Tudriqev may help restore an anti-tumor immune response in patients whose cancer had previously stopped responding to immunotherapy.
Tudriqev is injected directly into tumors once every two weeks for eight consecutive doses, with the dosage amount determined by the size of the tumor. A lower concentration is used for the first dose, followed by a higher concentration for all remaining doses. A second drug, nivolumab, is given intravenously beginning at week three of treatment.
“For patients with advanced melanoma who have exhausted immunotherapy options, today’s approval offers a meaningful new path forward — grounded in early evidence and backed by the accountability that accelerated approval demands,” said Megha Kaushal, M.D., MSc., Acting Deputy Director of the CBER Office of Therapeutic Products.
The safety and effectiveness of Tudriqev were evaluated in an open-label, multiregional, single-arm trial enrolling 140 adult patients with Stage IIIB, IIIC or IV unresectable advanced melanoma who experienced disease progression on at least eight consecutive weeks of prior anti-PD-1-based therapy. In the trial, 91 patients were evaluated and 24% of patients achieved an objective response. Responses had a median duration of 14.1 months.
The most common adverse reactions reported in more than 10% of patients were fatigue, fever (pyrexia), infections, chills, musculoskeletal pain, nausea, diarrhea, injection site reaction, headache, cough, influenza-like illness, rash, vomiting, itching (pruritus), arthralgia, constipation, decreased appetite, dizziness, dyspnea, hemorrhage, edema, and abdominal pain. Important safety warnings include the risk of accidentally spreading a herpes infection to close contacts, the possibility of a herpes infection developing or reactivating in the patient, and complications related to injection procedure.
On July 30, 2026, the FDA convened the Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for this application. The meeting included a public hearing section to hear from patients, patient advocates, clinicians and independent experts and a session for discussion and deliberation among committee members. The application was granted Breakthrough Therapy and Priority Review designations.
FDA granted the approval of Tudriqev to Replimune, Inc. The approval is granted under the FDA’s accelerated approval pathway based on objective response rate and duration of response. As a condition of accelerated approval, Replimune, Inc., is required to conduct post-approval trial(s) to verify and describe the clinical benefit of Tudriqev. Continued approval may be contingent upon verification of clinical benefit in confirmatory trial(s).
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
Source: U.S. Food and Drug Administration (FDA)
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