Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved trastuzumab emtansine for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either (i) received prior therapy for locally advanced or metastatic disease or (ii) developed disease recurrence during or within six months of completing adjuvant therapy.
This is written in the approval document as:
Treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: (i) Received prior therapy for locally advanced or metastatic disease, or (ii) Developed disease recurrence during or within six months of completing adjuvant therapy.
Citation
Trastuzumab Emtansine (Kadcyla) - 21 days, 2017, version number 2, NCCP National SACT Regimen, NCCP, viewed 01/04/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/breast/trastuzumab-emtansine-kadcyla%C2%AE-21-days.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 emtansine |