FDA approved Imlygic (talimogene laherparepvec) as the first oncolytic viral therapy in the U.S.
Imlygic, developed by Amgen, is indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. Imlygic has not been shown to improve overall survival or have an effect on visceral metastases.
Imlygic is a genetically modified herpes simplex virus type 1 designed to replicate within tumors and produce granulocyte-macrophage colony-stimulating factor, an immunostimulatory protein. Imlygic causes cell lysis rupturing tumors and releasing tumor-derived antigens, which along with GM-CSF, may promote an anti-tumor immune response. However, the exact mechanism of action is unknown, according to Amgen.