FDA panel backs T-Vec for melanoma

Panelists voted 22-1 to recommend approval of talimogene laherparepvec from Amgen Inc. (NASDAQ:AMGN) to treat regionally or distantly metastatic melanoma at a joint meeting of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee.

Panel members largely agreed that the single Phase III study had shown clinically meaningful benefit, particularly in patients with less advanced disease. They focused their analysis on subgroups of the latter, such as patients with less severe disease staging and those with smaller lesions. ...