What is the role of neratinib in the treatment of HER2-positive breast cancer?

Updated: May 14, 2019
  • Author: Maurie Markman, MD, MS; Chief Editor: Karl S Roth, MD  more...
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Answer

Answer

Neratinib is an irreversible tyrosine-kinse inhibitor of EGFR, HER1, HER2, and HER4. Dual blockade by antiangiogenic/HER2 agents (eg, neratinib) targeting HER and EGFR pathways produces greater inhibition of human breast cancer cell lines. In July 2017, the FDA approved neratinib for extended adjuvant therapy for early stage HER2 positive breast cancer following adjuvant trastuzumab-based therapy. [14]  The approval was based on the the phase 3 ExteNET trial, a multicenter, randomized, double-blind, placebo-controlled trial of neratinib following adjuvant trastuzumab treatment. After 2 years of follow-up, invasive disease-free survival (iDFS) was 94.2% in patients treated with neratinib, compared with 91.9% in those receiving placebo. [15]


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