Tepmetko (tepotinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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