Talimogene Laherparepvec: First Global Approval.

Talimogene laherparepvec (Imlygic™) is an oncolytic viral therapy that is being developed by BioVex (a subsidiary of Amgen) for the intralesional treatment of various cancers, including malignant melanoma. Talimogene laherparepvec is a genetically modified, live, attenuated, herpes simplex virus type 1 that is designed to promote an antitumour response through selective viral replication in tumour cells and stimulation of systemic antitumour immunity. In October 2015, talimogene laherparepvec was the first genetically modified, oncolytic viral therapy to be approved in the USA for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery, although it has not been shown to improve overall survival or have an effect on visceral metastases. Talimogene laherparepvec has been recommended for approval in adults with unresectable metastatic melanoma in the EU, and is being evaluated in several countries for use as neoadjuvant or combination therapy in malignant melanoma; it is also in development for soft tissue sarcoma and liver cancer in the USA. This article summarizes the milestones in the development of talimogene laherparepvec leading to this first approval in malignant melanoma.