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

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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