# Nintedanib

Nintedanib (Vargatef, Boehringer Ingelheim International GmbH) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + docetaxel | 2nd line, advanced | Adenocarcinoma only; After first-line chemotherapy |

## Products

### Vargatef

- Company: Boehringer Ingelheim International GmbH
- Target: Triple angiokinase inhibitor (VEGFR, PDGFR, FGFR)
- Class: Other protein kinase inhibitors
- ATC: L01EX09
- EU approval: 21 Nov 2014
- Label revised: 10 Jun 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/vargatef-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/vargatef-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/vargatef
- Biosimilars and generics: Nintedanib Accord, Nintedanib Viatris

Mechanism (SmPC section 5.1): Binds the ATP pocket of VEGFR1-3, PDGFRα/β and FGFR1-3, blocking signalling needed for endothelial and perivascular cell proliferation and survival; also inhibits FLT3, LCK and SRC.

## Label wording

- **Nintedanib** (Vargatef), Non-small cell lung cancer, 2nd line, advanced: “Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/vargatef-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/nintedanib