Neratinib is a potent irreversible tyrosine kinase inhibitor, that inhibits tumor growth and metastasis through the blocking of pan-HER family (HER1, HER2 and HER4) and downstream signal transduction. Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed in the United States as NERLYNX®(neratinib) tablets. Neratinib was also approved by EMA in Europe in September 2018.

Indication: HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, with increasing risk of disease recurrence, progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence. Patients with recurrent and metastatic HER2-positive breast cancer are usually incurable. The metastatic sites include contralateral breast, brain, lung, bone, etc. Brain metastasis is one of the leading causes of death.