Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that MET Exon 14 (Splice Site) status confers therapeutic sensitivity to Tepotinib in patients with Non-Small Cell Lung Cancer.

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 statement is based on a regulatory approval from the European Medicines Agency:

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.

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.