# Nintedanib

Source: https://onco.cc/drugs/nintedanib/  
OnCo record `nintedanib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Nintedanib is a triple angiokinase inhibitor pill (VEGFR, FGFR, PDGFR) approved for pulmonary fibrosis and, in the EU, for second-line lung adenocarcinoma with docetaxel. In mesothelioma the phase 2 part of LUME-Meso suggested slower progression in epithelioid disease, but the phase 3 part showed none, a much-cited warning about small randomised phase 2 signals.

## Summary

Nintedanib is a triple angiokinase inhibitor of VEGFR1-3, FGFR1-3 and PDGFR alpha and beta, designed to cut off tumour blood supply and stromal signalling. It is approved for idiopathic pulmonary fibrosis and, in the EU, for second-line lung adenocarcinoma with docetaxel. In mesothelioma, the LUME-Meso phase 2 suggested a PFS benefit in epithelioid disease, but the phase 3 part of the same trial showed none, with PFS 6.8 versus 7.0 months (HR 1.01) and no OS benefit. The programme is a frequently cited lesson in how unreliable small randomised phase 2 PFS signals can be in this disease. Boehringer Ingelheim developed it, and its oncology role is now limited to the EU lung indication. A plausible mechanism and an encouraging early trial are not enough until a large trial confirms them.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Tags: failure; lesson:phase-2-pfs-signal
- Brand: Ofev (fibrosis); Vargatef (NSCLC, EU)
- Modality: Small-molecule kinase inhibitor (VEGFR/FGFR/PDGFR)
- Mechanism: Triple angiokinase inhibitor of VEGFR1-3, FGFR1-3, PDGFRα/β.
- Approvals: EU 2014: Adenocarcinoma NSCLC after first-line chemotherapy, with docetaxel; US 2014: Idiopathic pulmonary fibrosis (non-oncology); England (NICE) 2015: Locally advanced, metastatic or locally recurrent non-small-cell lung cancer of adenocarcinoma histology progressing after first-line chemotherapy, with docetaxel

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Nintedanib
- EMA: Vargatef (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/vargatef
- Wikipedia: https://en.wikipedia.org/wiki/Nintedanib
- NICE TA347: nintedanib for previously treated locally advanced, metastatic or locally recurrent non-small-cell lung cancer: https://www.nice.org.uk/guidance/ta347

## Connected records

- cancers: [Adenocarcinoma of the lung](https://onco.cc/cancers/lung-adenocarcinoma/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Mesothelioma](https://onco.cc/cancers/mesothelioma/)
- technologies: [Anti-angiogenic therapy](https://onco.cc/technologies/antiangiogenic/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [FGFR2](https://onco.cc/targets/fgfr2/), [VEGF / VEGFR](https://onco.cc/targets/vegf/)
- companies: [Boehringer Ingelheim](https://onco.cc/companies/boehringer-ingelheim/)
- trials: [LUME-Lung 1](https://onco.cc/trials/lume-lung-1/), [LUME-Meso](https://onco.cc/trials/lume-meso/)
- terms: [Lung cancer drugs in England: what NICE has recommended](https://onco.cc/terms/lung-uk-drug-access/)
- pathways: [The angiogenic switch & tumour vessels](https://onco.cc/pathways/angiogenic-switch/)

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JSON: https://onco.cc/api/v1/entities/nintedanib.json