FDA Updates Neratinib Label in HER2+ Breast Cancer

Oct 3, 2019 – The FDA has approved a labeling supplement for neratinib for the extended adjuvant treatment of patients with HER2-positive early-stage breast cancer. The labeling supplement includes safety information based on interim results of the phase II CONTROL trial (NCT02400476), in which the addition of prophylactic treatment with loperamide plus budesonide reduced the discontinuation rate of neratinib due to associated diarrhea to 11% compared with 18% … (leggi tutto)