Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved afatinib for reimbursement as a monotherapy treatment option for the treatment of EGFR TKI-naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor activating EGFR mutation(s), as demonstrated by a validated test method.

This is written in the approval document as:

Treatment of Epidermal Growth Factor Receptor (EGFR) TKI- naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s).

Reimbursement

CDS

Citation

Afatinib Monotherapy, 2025, version number 5, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/6936/221_V4a_Afatinib.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	EGFR activating variants	Non-Small Cell Lung Cancer	Afatinib

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2013-12-20	Health Service Executive	Indication approved for reimbursement.