Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved neratinib for reimbursement as a treatment option for the extended adjuvant treatment of adults with early-stage hormone-receptor positive, HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.

This is written in the approval document as:

Extended adjuvant treatment of adults with early-stage hormone receptor-positive, HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.

Reimbursement

CDS

Citation

Neratinib Therapy, 2024, version number 2, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6596/720_v2_Neratinib.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	ER positive, HER2-positive, PR positive	Invasive Breast Carcinoma	Neratinib
HSE (1)	ER positive, HER2-positive	Invasive Breast Carcinoma	Neratinib
HSE (1)	HER2-positive, PR positive	Invasive Breast Carcinoma	Neratinib
HSE (1)	ER positive, ERBB2 amplification, PR positive	Invasive Breast Carcinoma	Neratinib
HSE (1)	ER positive, ERBB2 amplification	Invasive Breast Carcinoma	Neratinib
HSE (1)	ERBB2 amplification, PR positive	Invasive Breast Carcinoma	Neratinib

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2022-03-01	Health Service Executive	Indication approved for reimbursement.