Regulatory approval

Published by the Health Service Executive. Approved

As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

This is written in the approval document.

Reimbursement

ODMS

Citation

Trastuzumab Deruxtecan (Enhertu) Therapy, 2025, version number 3, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6661/776_v3a_Trastuzumab_Deruxtecan_Therapy.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	HER2-low	Invasive Breast Carcinoma	Trastuzumab deruxtecan

Contributions

Date	Contributor	Description
2025-07-01	Health Service Executive	Indication approved for reimbursement.
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database