APR 29 CTGTAC ODAC

The US FDA has scheduled a Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drug Advisory Committee for Wednesday, April 29, 2015. The committees will discuss biologics license application (BLA) 125518, for talimogene laherparepvec, submitted by Amgen, Inc. The investigational drug is an oncolytic immunotherapy for the treatment of patients with injectable regionally or distantly metastatic melanoma.

See the FDA Announcement