FDA Approves Talimogene Laherparepvec to Treat Metastatic Melanoma
, by NCI Staff
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.
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.