On August 6, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg) for use in adults with unresectable advanced cutaneous melanoma that progressed on a programmed death receptor-1 (PD-1)–blocking antibody regimen. The approved indication is for Tudriqev given in combination with nivolumab for patients with treatment-resistant, anti-PD-1–refractory melanoma.
The approval was granted to Replimune, Inc., under the FDA’s accelerated approval pathway based on objective response rate and duration of response. Continued approval may depend on verification of clinical benefit in required post-approval confirmatory trials.
Tudriqev is a genetically modified oncolytic viral therapy based on herpes simplex virus type 1 (HSV-1). The virus is engineered to selectively infect and replicate within tumor cells, leading to oncolysis (tumor cell lysis). Viral replication within the tumor also releases tumor antigens and immune-stimulatory signals that can help recruit and activate the host immune system against cancer cells.
When combined with nivolumab, an anti–PD-1 monoclonal antibody, Tudriqev is intended to both locally debulk tumors via direct oncolysis and enhance systemic anti-tumor immune responses, potentially restoring sensitivity to PD-1 pathway blockade in tumors that had previously become refractory.
Tudriqev is administered by direct intratumoral injection. The dosing schedule is once every two weeks for a total of eight consecutive doses. The protocol uses a lower viral concentration for the initial (first) dose and a higher concentration for all subsequent doses, with the administered volume determined by tumor size.
Nivolumab is administered intravenously beginning at week three of treatment, concurrent with the ongoing intratumoral Tudriqev dosing schedule.
The FDA’s decision was supported by data from an open-label, multiregional, single-arm clinical trial that enrolled 140 adult patients with unresectable Stage IIIB, IIIC or IV melanoma who had disease progression on at least eight consecutive weeks of prior anti–PD-1–based therapy. Of the enrolled population, 91 patients were evaluable for response.
In the evaluable cohort, the objective response rate (ORR) was 24%. The median duration of response among responders was 14.1 months. The FDA noted these results, together with input from clinical experts and patient advocates, when considering benefit for this high unmet-need population.
The application was granted Breakthrough Therapy and Priority Review designations prior to approval. The FDA also convened the Cellular, Tissue, and Gene Therapies Advisory Committee on July 30, 2026, which included a public hearing to gather perspectives from patients, advocates, clinicians and independent experts.
The most common adverse reactions observed in more than 10% of patients included 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 highlighted by the FDA include the potential for accidental transmission of the modified herpes virus to close contacts, the possibility of developing or reactivating a herpes infection in the treated patient, and complications related to the intratumoral injection procedure. These risks inform patient counseling, infection control precautions, and monitoring during and after treatment.
Clinicians and patients should weigh the reported benefits in objective response and response durability against the safety profile and the limitations inherent to the single-arm trial design that supported accelerated approval.
The FDA considered clinical data as well as stakeholder input in its review. The applicant’s submission was reviewed with Breakthrough Therapy and Priority Review designations, and the Cellular, Tissue, and Gene Therapies Advisory Committee met on July 30, 2026, to discuss the application and hear public testimony from affected patients, advocates and clinical experts.
Because approval was granted under the accelerated approval pathway based on surrogate measures of clinical benefit (objective response rate and duration of response), Replimune, Inc., is required to conduct post-approval confirmatory trials to verify and describe the therapy’s clinical benefit. Continued marketing approval may be contingent on the results of these required studies.
FDA officials emphasized the unmet need for effective therapies in patients whose melanoma has progressed after PD-1–blocking therapy and described Tudriqev in combination with nivolumab as a new treatment option offering measurable responses and durable benefit for a subset of patients. The agency also communicated the importance of post-marketing study commitments and the known safety concerns associated with an engineered HSV-1 oncolytic agent.
For further information or media inquiries, the FDA provided contact details in the original announcement. The press release also noted the FDA’s role in assuring the safety and effectiveness of biologic therapies and listed the content as current as of August 6, 2026.