Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved neratinib for reimbursement as a treatment option for the extended adjuvant treatment of adults 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:
Extended adjuvant treatment of adults with early-stage hormone receptor-positive, HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.
Citation
Neratinib Therapy, 2022, version number 1, NCCP National SACT Regimen, NCCP, viewed 11/01/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/breast/720.pdfTherapeutic 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 |