Regulatory approval

Published by the Health Service Executive. Approved

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).

This is written in the approval document.

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.