Regulatory approval

Published by the European Medicines Agency. Approved

TEPMETKO as monotherapy is indicated 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.

Citation

Merck Europe B.V. Tepmetko (tepotinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tepmetko-epar-product-information_en.pdf. Revised November 2023. Accessed March 23, 2024.

Therapeutic response

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

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

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2022-02-16	European Medicines Agency	Indication received approval from the European Commission.