Briefing Summary: US FDA Posts Advisory Committee Materials for Amgen’s T-Vec to Treat Metastatic Melanoma – APR 29, 2015 (CTGTAC-ODAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Wednesday, April 29, 2015 joint meeting of the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC). The committees will discuss a Biologics License Application (BLA) 125518, submitted by Amgen, Inc. (Amgen), for talimogene laherparepvec (T-Vec), an oncolytic immunotherapy proposed for the treatment of patients with injectable regionally or distantly metastatic melanoma.