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

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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