Regulatory approval

Published by the Health Service Executive. Approved

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.

This is written in the approval document.

Reimbursement

ODMS

Citation

Tepotinib Therapy, 2025, version number 2, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6868/823_V2_Tepotinib_Therapy.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	MET Exon 14 (Splice Site)	Non-Small Cell Lung Cancer	Tepotinib
HSE (1)	MET Exon 14 (Deletion)	Non-Small Cell Lung Cancer	Tepotinib

Contributions

Date	Contributor	Description
2024-08-01	Health Service Executive	Indication approved for reimbursement.
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database