Puma Biotechnology (PBYI) announced that it has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for PB272 (Neratinib). The potential indication is for the extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with Trastuzumab (Herceptin)-based adjuvant therapy. The submission is based on the ExteNET Phase III study which showed treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.67, p = 0.009).