Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved tepotinib for reimbursement as a monotherapy treatment option for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
This is written in the approval document as:
As monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
Citation
Tepotinib Therapy, 2024, version number 1a, NCCP National SACT Regimen, NCCP, viewed 19/08/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/lung/823-tepotinib-therapy.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | MET Exon 14 (Splice Site) | Non-Small Cell Lung Cancer | Tepotinib | |
| Sensitivity (+) | MET Exon 14 (Deletion) | Non-Small Cell Lung Cancer | Tepotinib |