The Medical Letter on Drugs and Therapeutics
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1539
Neratinib (Nerlynx) for HER2-Positive Breast Cancer
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The FDA has approved the oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) for extended adjuvant treatment of adults with early-stage, human epidermal growth factor receptor 2 (HER2)-positive breast cancer, following adjuvant trastuzumab (Herceptin)-based therapy. HER2 is overexpressed in about 20% of breast cancers. Up to 30% of early-stage, HER2-positive breast cancer cases treated with trastuzumab-based adjuvant therapy recur.

MECHANISM OF ACTION — Neratinib binds irreversibly to HER2 and other enzymes that promote cell growth, resulting in reduced signaling, cell cycle arrest, and apoptosis.

CLINICAL STUDIES — In a double-blind trial (ExteNET), 2840 women with stage 1-3, HER2-positive breast cancer who had completed neoadjuvant and adjuvant trastuzumab-based therapy within the previous two years were randomized to receive oral neratinib 240 ... more      

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Title: Neratinib (Nerlynx) for HER2-Positive Breast Cancer
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