- Puma Biotechnology (NASDAQ:PBYI) announces 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). The 2-year invasive disease-free survival (DFS) rate for the neratinib arm was 93.9% compared to 91.6% for placebo. In a subgroup of breast cancer patients positive for hormone receptor (HR+), those receiving PB272 experienced a 49% reduction in the risk of disease recurrence or death (hazard ratio=0.51, p=0.001). The two-year PFS rates were 95.4% and 91.2%, respectively.
- A New Drug Application (NDA) is on tap in the U.S. in the next month or two.