Neratinib (Puma Biotechnology) is an irreversible tyrosine kinase inhibitor that blocks signal transduction through the human epidermal growth factor receptor (HER)1, HER2, HER4, and epidermal growth factor receptor kinases. Inhibition of these kinase domains is thought to lead to apoptosis and down-regulation of the ErbB signaling pathway. Furthermore, irreversible pan-HER drugs illicit prolonged blockade of multiple targets, a mechanism thought to overcome signaling redundancy and adaptability.
Puma Biotechnology has filed regulatory submissions for neratinib (Puma Biotechnology) with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in the extended adjuvant setting based on data from the Phase III ExteNET study. The trial demonstrated that neratinib can fulfill an unmet need in human epidermal growth factor receptor 2-positive (HER2+) breast cancer by improving disease-free survival (DFS) rates in patients who have previously received Herceptin (trastuzumab; Genentech/Roche/Chugai) as an adjuvant therapy. Neratinib is the first targeted therapy to demonstrate a statistically significant clinical benefit in this lucrative treatment setting, which will differentiate it from other established drugs in the HER2+ breast cancer market.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 neratinib : Breast cancer: HER2-positive
LIST OF FIGURES
11 Figure 1: Neratinib – SWOT analysis in HER2-positive breast cancer
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of neratinib for HER2-positive
12 Figure 3: Datamonitor Healthcare drug assessment summary of neratinib for HER2-positive
LIST OF TABLES
4 Table 1: Neratinib drug profile for HER2-positive breast cancer
7 Table 2: Overview of ongoing Phase III trial for neratinib in HER2-positive breast cancer
8 Table 3: Phase III trial data for neratinib in HER2-positive breast cancer
9 Table 4: Overview of key Phase II trial data for neratinib in HER2-positive breast cancer
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