Background Analysis: US FDA Joint Advisory Committee to Review Amgen’s T-Vec to Treat Metastatic Melanoma – APR 29, 2015 (CTGTAC-ODAC)
The US FDA has scheduled a joint meeting of the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC) for Wednesday, April 29, 2015 to discuss Biologics License Application (BLA) 125518, submitted by Amgen, Inc. (Amgen), for talimogene laherparepvec (T-Vec), an oncolytic immunotherapy for the treatment of patients with injectable regionally or distantly metastatic melanoma. The drug was initially developed by BioVex, Inc. under the name OncoVEXGM-CSF until the company was acquired by Amgen in 2011.