Regulatory approval

Published by the Health Service Executive. Approved

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.

Reimbursement

ODMS

Citation

Trastuzumab Emtansine (Kadcyla) - 21 days, 2021, version number 4, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6547/206_v4_Trastuzumab_Emtansine_21days.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	HER2-positive	Invasive Breast Carcinoma	Trastuzumab emtansine

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2015-08-01	Health Service Executive	Indication approved for reimbursement.