Irreversible pan-HER tyrosine kinase inhibitor
Canada, USA, Argentina, Europe, Singapore, Hong Kong, China, Australia
· Early Breast Cancer : As a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
· Metastatic Breast Cancer : In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
· Early Breast Cancer : As a single agent, for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.
Gobal treatment guideline
1. NCCN guideline 2020, Breast Cancer (National Comprehensive Cancer Network)
Early Breast Cancer
Consider extended adjuvant neratinib following adjuvant trastuzumab containing therapy for patient with HR-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 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 18, 4 (2020). NCCN Guidelines v1. 2019. Central Nervous System Cancers
2. ESMO guideline 2019, Early breast cancer (European Society for Medical Oncology)
Early Breast Cancer
Extended anti-HER2 therapy with neratinib may be considered in selected high-risk patients, not previously treated with dual blockade, and with appropriate diarrhoea 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.