FDA Approves Talimogene Laherparepvec to Treat Metastatic Melanoma

November 25, 2015, by NCI Staff

Melanoma cells dividing

T-VEC, an oncolytic virus, works by infecting and killing tumor cells, like these dividing melanoma cells, and stimulating an immune response against cancer cells throughout the body.

Credit: Wellcome Images, CC BY-NC-ND 4.0

On October 27, the U.S. Food and Drug Administration (FDA) approved the first oncolytic virus therapy, talimogene laherparepvec (T-VEC, or Imlygic®).The agency approved T-VEC for the treatment of some patients with metastatic melanoma that cannot be surgically removed.

The approval was based on the results of a multicenter phase III clinical trial of patients with metastatic melanoma lesions in the skin and lymph nodes. 

Substantially more patients in the trial treated with T-VEC had a decrease in the size of their skin and lymph node lesions that lasted at least 6 months compared with patients treated with granulocyte macrophage colony-stimulating factor.

Read more about the trial results on which the FDA based its approval.

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