Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with alterations leading to mesenchymal-epithelial transition factor gene exon 14 (MET exon 14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

This is written in the approval document as:

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.

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.

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