Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved trastuzumab (subcutaneous - 21 days) in combination with an aromatase inhibitor as a treatment option for the treatment of HER2 positive, hormone-receptor positive metastatic breast cancer not previously treated with trastuzumab for patients who are postmenopausal. The corresponding European Medicines Agency approval for this indication cites the clinical trial BO16216 as rationale for the approval where Herceptin (trastuzumab) and anastrozole were administered.
This is written in the approval document as:
HER2 positive metastatic breast cancer (MBC) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.
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 (+) | ER positive, HER2-positive, PR positive | Invasive Breast Carcinoma | Anastrozole, Trastuzumab | |
| Sensitivity (+) | ER positive, HER2-positive | Invasive Breast Carcinoma | Anastrozole, Trastuzumab | |
| Sensitivity (+) | HER2-positive, PR positive | Invasive Breast Carcinoma | Anastrozole, Trastuzumab |