"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.


"The first oral extended adjuvant therapy HER2 positive 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. Neratinib was approved in Korea for the extended adjuvant treatment of patients with early stage hormone receptor positive, HER2 positive breast cancer who completed adjuvant trastuzumab-based therapy less than one year ago as a single agent.

Irreversible pan-HER tyrosine kinase inhibitor

Irreversible pan-HER tyrosine kinase inhibitor

Early Breast Cancer


Consider extended adjuvant neratinib following adjuvant trastuzumab containing therapy for patient with HR-positive, HER2-positive disease with a perceived high risk of recurrence


Metastatic or Recurrent Breast Cancer


In combination with capecitabine, for the treatment of patients with metastatic or recurrent HER2 positive breast cancer

Metastatic or Recurrent Breast Cancer - Brain Metastases


In combination with capecitabine or paclitaxel, for the treatment of newly diagnosed patients with metastatic or recurrent HER2-positive breast cancer with brain metastases


- Gradishar, William J., et al. "NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)." 

- Journal of the National Comprehensive Cancer Network 28, 4 (2021). NCCN Guidelines v4. 2021. Breast Cancer - Louis Burt Nabors, et al. "NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)." 

- Journal of the National Comprehensive Cancer Network 4, 6 (2021). NCCN Guidelines v1. 2021. Central Nervous System Cancers

Early Breast Cancer


Extended anti-HER2 therapy with neratinib may be considered in selected HER2-positive high-risk patients for recurrence, not previously treated with dual blockade, and with appropriate diarrhea prophylaxis and management


Cardoso, F., et al. "Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up." Annals of Oncology 30, 8 (2019): 1194-1220.

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