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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
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