# Capmatinib

Capmatinib (Tabrecta, Novartis Europharm Limited) 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 |
|---|---|---|---|
| Alterations leading to METex14 skipping | Monotherapy | 2nd line, advanced | After prior treatment with immunotherapy and/or platinum-based chemotherapy |

## Products

### Tabrecta

- Company: Novartis Europharm Limited
- Target: MET tyrosine kinase inhibitor
- Class: Other protein kinase inhibitors
- ATC: L01EX17
- EU approval: 20 Jun 2022
- Label revised: 27 Aug 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tabrecta-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tabrecta-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tabrecta

Mechanism (SmPC section 5.1): Capmatinib inhibits MET phosphorylation and downstream signalling, blocking the proliferation and survival of MET-dependent cancer cells.

## Label wording

- **Capmatinib** (Tabrecta), Non-small cell lung cancer, 2nd line, advanced: “Tabrecta 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/tabrecta-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/capmatinib