Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved trastuzumab deruxtecan (Enhertu) for reimbursement as a monotherapy treatment option for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.

This is written in the approval document as:

As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.

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.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
HSE (1) HER2-positive Invasive Breast Carcinoma Trastuzumab deruxtecan