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 approved in combination with nivolumab for adults with unresectable advanced cutaneous melanoma who have progressed on a PD-1-blocking antibody-based regimen. This patient population currently faces very limited treatment options.
How It Works
Tudriqev is based on a modified herpes simplex virus type 1 (HSV-1) engineered to selectively target and destroy cancer cells. Once injected into tumors, the virus replicates and breaks 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, the therapy aims to restore an anti-tumor immune response in patients whose cancer had stopped responding to immunotherapy.
Clinical Data
The approval is supported by an open-label, single-arm trial involving 140 patients with Stage IIIB, IIIC or IV unresectable advanced melanoma who had progressed after at least eight weeks of prior anti-PD-1 therapy. Among 91 evaluable patients, 24% achieved an objective response. Responses lasted a median of 14.1 months.
Safety Profile
Common adverse reactions reported in more than 10% of patients include fatigue, fever, infections, chills, musculoskeletal pain, nausea, diarrhea, injection site reaction, headache, cough, flu-like illness, rash, vomiting, itching, joint pain, constipation, decreased appetite, dizziness, shortness of breath, bleeding, swelling, and abdominal pain. Safety warnings cover risks of accidental herpes transmission to close contacts, potential herpes reactivation in patients, and injection-related complications.
Dosing
Tudriqev is injected directly into tumors once every two weeks for eight doses. A lower concentration is used for the first dose, followed by a higher concentration for subsequent doses. Nivolumab is administered intravenously starting at week three.
Regulatory Pathway
The application received Breakthrough Therapy and Priority Review designations. On July 30, 2026, the FDA held an advisory committee meeting including a public hearing with patients and experts. The approval follows 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 trials to verify clinical benefit," the FDA stated. Continued approval depends on confirmation in these trials.
"This milestone gives oncologists a meaningful new tool — and more patients a fighting chance," said Karim Mikhail, Acting Director of CBER.
The approval was granted to Replimune, Inc.
