"The first oral extended adjuvant therapy HER2 positive breast cancer"
Neratinib, an oral HER2 targeted therapy, was approved by the U.S. Food and Drug Administration in 2017 and by the European Commission in 2018. It has been included as a recommended treatment option in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for early and metastatic breast cancer. Neratinib is approved in Korea for the extended adjuvant treatment of patients with early stage hormone receptor positive, HER2 positive breast cancer as a single agent who completed adjuvant trastuzumab-based therapy less than one year ago.