European Panel Recommends Against Neratinib for HER2-Positive Breast Cancer

February 23, 2018 – European regulators have recommended against approving a marketing authorization application (MAA) for the use of neratinib as extended adjuvant treatment for women with early stage HER2-positive breast cancer. In January, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency informed Puma, the manufacturer of neratinib, about a negative trend vote following a meeting to discuss the MAA. The … (leggi tutto)