FDA accepts for review NDA for PB 272 (neratinib) to treat early stage HER2-overexpressed/amplified breast cancer.-Puma Biotechnology

Puma Biotechnology, Inc. announced that the FDA has accepted for review the New Drug Application (NDA) for its lead product candidate PB 272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy. The submission is supported by the results of the ExteNET Phase III study, in which 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% and the 2-year invasive DFS rate for the placebo arm was 91.6%.

Comment: The Marketing Authorization Application (MAA) for neratinib has been validated by the European Medicines Agency in August 2016.

Although the use of trastuzumab in the adjuvant setting has led to a reduction in disease recurrence in patients with early stage HER2-positive breast cancer, there remains an unmet clinical need to further reduce the risk of recurrence and improve outcome following trastuzumab therapy.