FDA to Review Neratinib as Adjuvant Tx for HER2+ Breast Cancer

The NDA is based on results from a randomized, double-blind, placebo-controlled Phase 3
The NDA is based on results from a randomized, double-blind, placebo-controlled Phase 3

Puma Biotechnology announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for PB272 (oral neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab-based therapy. 

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The NDA was based on results from the ExteNET study, a randomized, double-blind, placebo-controlled Phase 3 trial which evaluated neratinib vs. placebo after adjuvant treatment with trastuzumab (Herceptin; Genentech) in 2,840 women with early stage HER2-positive breast cancer. The study showed that treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death vs. placebo (HR=0.67, P=0.009). Additionally, the 2-year invasive disease free survival (DFS) rate for the neratinib arm was 93.9% compared to 91.6% for the placebo arm. Detailed results of the study were published online in The Lancet Oncology on February 10, 2016.

Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4.

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