Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized neratinib 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.
This is written in the approval document as:
Nerlynx is indicated 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.
Citation
Pierre Fabre Medicament. Nerlynx (neratinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/nerlynx-epar-product-information_en.pdf. Revised June 2023. Accessed March 20, 2024.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 | |
| Sensitivity (+) | ER positive, ERBB2 amplification, PR positive | Invasive Breast Carcinoma | Neratinib | |
| Sensitivity (+) | ER positive, ERBB2 amplification | Invasive Breast Carcinoma | Neratinib | |
| Sensitivity (+) | ERBB2 amplification, PR positive | Invasive Breast Carcinoma | Neratinib |