talimogene laherparepvec

FDA Drug Profile — Imlygic

Drug Details

Generic Name
talimogene laherparepvec
Brand Names
Imlygic
Application Number
BLA125518
Sponsor
Amgen Inc
NDC Codes
4
Dosage Forms
INJECTION, SUSPENSION
Routes
INTRALESIONAL
Active Ingredients
TALIMOGENE LAHERPAREPVEC

Indications and Usage

1 INDICATIONS AND USAGE IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. ( 1 )