On October 27, 2015, the FDA approved talimogene laherparepvec for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.50,51

On December 16, 2015, talimogene laherparepvec received approval by the European Commission for the treatment of adults with unresectable melanoma that is regionally or distally metastatic (stage IIIB, IIIC, and IVM1a) with no bone, brain, lung, or other visceral disease.52,53

Talimogene laherparepvec is a genetically modified HSV type 1 virus derived by functional deletion of two genes, ICP34.5 and ICP47, and insertion of the coding sequence for human GM-CSF. It is designed to replicate within tumors and produce the immune stimulatory GM-CSF protein. It causes lysis of tumors that is followed by release of tumor-derived antigens. These antigens, together with virally derived GM-CSF, may promote an antitumor immune response.50–53