# Tepotinib

Tepotinib (Tepmetko, Merck Europe B.V.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: MET (1).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping | Monotherapy | 2nd line, advanced | After prior treatment with immunotherapy and/or platinum-based chemotherapy |

## Products

### Tepmetko

- Company: Merck Europe B.V.
- Target: MET inhibitor
- Class: Other protein kinase inhibitors
- ATC: L01EX21
- EU approval: 16 Feb 2022
- Label revised: 8 Oct 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tepmetko-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tepmetko-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tepmetko

Mechanism (SmPC section 5.1): A reversible ATP-competitive small molecule inhibitor that blocks MET phosphorylation and downstream PI3K/Akt and MAPK/ERK signalling.

## Label wording

- **Tepotinib** (Tepmetko), Non-small cell lung cancer, 2nd line, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tepmetko-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/tepotinib