FDA Panel Supports Neratinib Approval for HER2+ Breast Cancer

May 24, 2017 – The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12-4 recommending approval of neratinib for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following postoperative trastuzumab. ODAC based its recommendation on data from the phase III ExteNET trial and the phase II CONTROL trial. In the primary analysis of the ExteNET trial, the invasive disease-free survival (iDFS) rate at 2 years … (leggi tutto)