The Food and Drug Administration on August 6, 2026 granted accelerated approval to Tudriqev, a genetically engineered oncolytic virus, for adults with unresectable advanced cutaneous melanoma whose disease has progressed on an anti-PD-1 immunotherapy. The drug, made by Replimune, is used together with the checkpoint inhibitor nivolumab.
Regulators cleared the therapy in combination with nivolumab for a patient group with few remaining options. Nivolumab, sold as Opdivo by Bristol Myers Squibb, is a PD-1 blocking antibody that helps the immune system attack tumors.
How the virus therapy works
Tudriqev, known scientifically as vusolimogene oderparepvec-wtpg, is built on a modified herpes simplex type 1 virus. According to the FDA, the virus is engineered to selectively enter cancer cells, replicate inside them, and break them apart, while triggering the immune system to recognize and attack the tumor.
The virus also carries a gene for GM-CSF, an immune signaling protein that helps activate the body's dendritic cells. Because the therapy must reach the tumor directly, it is given as an injection into the tumor, with imaging guidance for deep or internal lesions.
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Oncolytic virus therapy is not entirely new territory. Amgen's talimogene laherparepvec (Imlygic) was approved for melanoma back in 2015. Tudriqev is the second such therapy for melanoma to reach the US market and is designed for use after anti-PD-1 treatment fails.
The trial behind the approval
The approval rests on the IGNYTE trial, an open-label, single-arm study of 140 adults with Stage IIIB, IIIC or IV melanoma whose cancer had progressed on at least eight weeks of anti-PD-1 therapy. Among 91 patients who had at least one non-injected lesion to evaluate, the objective response rate was 24.2 percent, and responses lasted a median of 14.1 months.
Serious adverse reactions were reported in 35 percent of patients, and 2.9 percent stopped treatment permanently because of side effects. The most common side effects were nausea, diarrhea, vomiting, constipation, fatigue, fever and reactions at the injection site.
The FDA also flagged specific risks tied to the live virus, including the possibility of spreading herpes infection to close contacts and reactivating herpes infection in patients. Anyone considering the treatment should discuss those risks and their personal medical history with their oncologist.
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What accelerated approval means
Accelerated approval lets the FDA clear a drug for a serious disease based on measures like tumor response rather than survival data. Replimune must now confirm the benefit in a larger study, the ongoing Phase 3 IGNYTE-3 trial, or the approval can be withdrawn.
The route to approval was unusually rocky. The FDA had twice rejected earlier applications because of concerns about the single-arm design, before an advisory committee voted 10-3 on July 30 that the IGNYTE data were interpretable and clinically meaningful.
"For patients with advanced melanoma who have exhausted immunotherapy options, today's approval offers a meaningful new path forward," Megha Kaushal, acting deputy director of the CBER Office of Therapeutic Products at the FDA, said in the agency's announcement.
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