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-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 as:

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.

Citation

Trastuzumab Deruxtecan (Enhertu) Therapy, 2025, version number 3b, NCCP National SACT Regimen, NCCP, viewed 01/10/2025, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/breast/776-trastuzumab-deruxtecan-enhertu-therapy.pdf

Therapeutic response

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

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) HER2-low Invasive Breast Carcinoma Trastuzumab deruxtecan