Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved osimertinib for reimbursement as a monotherapy treatment option for the adjuvant treatment after complete tumor resection for adult patients with stae IB-IIIA non-small cell lung cancer (NSCLC) whose tumor has epidermal growth factor receptor (EGFR) exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations.
This is written in the approval document as:
As monotherapy for adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC) whose tumour has epidermal growth factor receptor (EGFR) exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations.
Citation
Osimertinib Monotherapy, 2024, version number 5, NCCP National SACT Regimen, NCCP, viewed 04/04/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/lung/353-osimertinib-monotherapy.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | EGFR Exon 19 (Deletion) | Non-Small Cell Lung Cancer | Osimertinib | |
| Sensitivity (+) | EGFR p.L858R | Non-Small Cell Lung Cancer | Osimertinib |