U.S. FDA has approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes. Imlygic is manufactured by BioVex Inc., a subsidiary of Amgen Inc., based in Thousand Oaks, California. Imlygic is a genetically modified herpes simplex virus type 1 designed to replicate within tumors and produce an immunostimulatory protein called granulocyte-macrophage colony-stimulating factor (GM-CSF). Imlygic causes cell lysis, or death, which ruptures tumors, releasing tumor-derived antigens, which along with GM-CSF, may promote an anti-tumor immune response.
Melanoma, one type of skin cancer, is the leading cause of skin cancer related deaths, and is most often caused by exposure to ultraviolet (UV) light. Metastatic melanoma is one of the most difficult-to-treat cancers because it is often insensitive to chemotherapy. Amgen intends to make Imlygic available to patients in the U.S. within a week. Amgen anticipates the average cost of Imlygic therapy to be approximately $65,000.