Regulatory approval
Published by the Health Canada.
Health Canada approved neratinib for the extended adjuvant treatment of women with early-stage hormone receptor positive and HER2-overexpressed/amplified breast cancer, within one year after completion of trastuzumab-based adjuvant therapy.
This is written in the approval document as:
NERLYNX (neratinib) is indicated for the extended adjuvant treatment of women with early-stage hormone receptor positive and HER2-overexpressed/amplified breast cancer, within one year after completion of trastuzumab-based adjuvant therapy.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | ER positive, HER2-positive, PR positive | Invasive Breast Carcinoma | Neratinib | |
| Sensitivity (+) | ER positive, HER2-positive | Invasive Breast Carcinoma | Neratinib | |
| Sensitivity (+) | HER2-positive, PR positive | Invasive Breast Carcinoma | Neratinib |