Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved trastuzumab (subcutaneous - 21 days) for reimbursement as a monotherapy treatment option for the treatment of HER2 positive metastatic breast cancer (MBC) in patients who have received at least two chemotherapy regimens for their metastatic disease. The indication further notes that prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
This is written in the approval document as:
HER2 positive metastatic breast cancer (MBC) as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
Citation
Trastuzumab Subcutaneous 21 days - Metastatic Breast Cancer, 2021, version number 4, NCCP National SACT Regimen, NCCP, viewed 21/07/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/breast/272.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | HER2-positive | Invasive Breast Carcinoma | Trastuzumab |