FDA committees to discuss Amgen's melanoma therapy

FDA's Cellular, Tissue and Gene Therapies Advisory Committee and its Oncologic Drug Advisory Committee will hold a joint meeting on April 29 to discuss a BLA from Amgen Inc. (NASDAQ:AMGN) for its oncolytic immunotherapy talimogene laherparepvec to treat metastatic melanoma.

The modified herpes simplex virus type 1 (HSV-1) encoding GM-CSF has an Oct. 27 PDUFA date. Amgen said last month that FDA postponed the date from July 28 and requested additional manufacturing data, which Amgen subsequently submitted. ...