FDA Schedules ODAC Meeting for Neratinib in HER2+ Breast Cancer

April 17, 2017 – The FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) hearing for May 24, 2017, to discuss a new drug application (NDA) for neratinib as a treatment for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab, according to a statement from the developer of the TKI, Puma Biotechnology. The NDA for neratinib, which the FDA accepted on September 20, 2016, is based on findings from … (leggi tutto)