Regulatory approval
Published by the Health Service Executive.
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).
Citation
Afatinib Monotherapy, 2020, version number 4, NCCP National SACT Regimen, NCCP, viewed 16/12/2023, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/lung/221.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | EGFR oncogenic variants | Non-Small Cell Lung Cancer | Afatinib |