Talimogene laherparepvec regulatory update

FDA’s Cellular, Tissue and Gene Therapies and Oncologic Drugs advisory committees voted 22-1 to recommend approval of talimogene laherparepvec from Amgen to treat regionally or distantly metastatic melanoma. The BLA for the modified herpes simplex virus type 1 (HSV-1) carrying GM-CSF has an Oct. 27 PDUFA date. An MAA is under review by EMA.

Panel members largely agreed that the single Phase III trial 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. Several panelists thought the indication should be restricted to subgroups of patients that benefited most in the trial, such as those who did not have substantial visceral metastatic disease. ...