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WASHINGTON -- The FDA has approved a first-of-its-kind oncolytic viral therapy for melanoma.

Following a near-unanimous advisory committee vote in favor of approval in April, the FDA will allow marketing of talimogene laherparepvec (T-VEC, Imlygic). The agent consists of a genetically modified live oncolytic herpes virus and the gene encoding for granulocyte-macrophage colony-stimulating factor (GM-CSF), which stimulates an immune response against the tumor. T-VEC is injected directly into unresectable melanoma lesions in the skin and lymph nodes.

"Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat," said , director of the FDA's Center for Biologics Evaluation and Research. "This approval provides patients and healthcare providers with a novel treatment for melanoma."

Data supporting the approval application came from a study involving 436 patients with metastatic melanoma. The patients were randomized 2:1 to T-VEC or subcutaneous GM-CSF. The primary endpoint was durable response rate (DRR, objective response for at least 6 months).

The primary analysis showed a DRR of 16.3% with T-VEC and 2.1% with GM-CSF (OR 8.9, P<0.001). The overall response rate also was higher with T-VEC (26.4% versus 5.7%). Median overall survival, a secondary endpoint, was 23.3 months with T-VEC and 18.9 months with GM-CSF.

The most frequent adverse events (all grades) were fatigue, chills, fever, nausea, flu-like symptoms, and injection-site pain. The only grade 3/4 adverse event associated with T-VEC treatment was cellulitis, occurring in 2.1% of patients.

T-VEC is manufactured by BioVex, a subsidiary of Amgen.

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