Talimogene laherparepvec (Imlygic)

General information

Class/mechanism: Genetically modified oncolytic viral therapy. Talimogene laherparepvec (Imlygic) is a live, attenuated Herpes Simplex Virus-1 (HSV-1) that has been genetically modified to express human granulocyte-macrophage colony-stimulating factor (huGM-CSF). The modified virus is able to reproduce inside of tumors. The exact mechanism of action is unknown, but the anti-tumor response may be due to the expression of huGM-CSF. It has been observed to cause tumor lysis and release of tumor-derived antigens.
Route: SC (intralesional injection)
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Melanoma

Patient drug information

• Talimogene laherparepvec (Imlygic) package insert

History of changes in FDA indication

• 2015-10-27: FDA approved for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. (Based on OPTiM)

History of changes in EMA indication

• 2015-12-16: Initial authorization

Also Known As

• Generic name: T-VEC
• Brand names: Imlygic, OncoVEX^GM-CSF