{"entity":{"id":"nintedanib","kind":"drug","name":"Nintedanib","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Nintedanib","links":[{"label":"EMA: Vargatef (EPAR)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/vargatef"},{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Nintedanib"},{"label":"NICE TA347: nintedanib for previously treated locally advanced, metastatic or locally recurrent non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta347"}],"tags":["failure","lesson:phase-2-pfs-signal"],"related":[],"cancers":["mesothelioma","lung-cancer","lung-adenocarcinoma"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":["vegf","fgfr2"],"drugs":[],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":[],"trials":["lume-meso"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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":[{"region":"EU","year":2014,"indication":"Adenocarcinoma NSCLC after first-line chemotherapy, with docetaxel"},{"region":"US","year":2014,"indication":"Idiopathic pulmonary fibrosis (non-oncology)"},{"region":"England (NICE)","year":2015,"indication":"Locally advanced, metastatic or locally recurrent non-small-cell lung cancer of adenocarcinoma histology progressing after first-line chemotherapy, with docetaxel","note":"TA347, published 22 July 2015, with the discount agreed in the patient access scheme."}],"mechanismSteps":["Blocks VEGFR, FGFR, and PDGFR signalling in endothelial and stromal cells","Reduces angiogenesis and fibroblast activation","In mesothelioma, no meaningful effect on tumour progression in phase 3"],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/nintedanib/","neighbours":{"cancer":[{"id":"lung-adenocarcinoma","kind":"cancer","name":"Adenocarcinoma of the lung","route":"/cancers/lung-adenocarcinoma/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"mesothelioma","kind":"cancer","name":"Mesothelioma","route":"/cancers/mesothelioma/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"fgfr2","kind":"target","name":"FGFR2","route":"/targets/fgfr2/"},{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"company":[{"id":"boehringer-ingelheim","kind":"company","name":"Boehringer Ingelheim","route":"/companies/boehringer-ingelheim/"}],"trial":[{"id":"lume-lung-1","kind":"trial","name":"LUME-Lung 1","route":"/trials/lume-lung-1/"},{"id":"lume-meso","kind":"trial","name":"LUME-Meso","route":"/trials/lume-meso/"}],"term":[{"id":"lung-uk-drug-access","kind":"term","name":"Lung cancer drugs in England: what NICE has recommended","route":"/terms/lung-uk-drug-access/"}],"pathway":[{"id":"angiogenic-switch","kind":"pathway","name":"The angiogenic switch & tumour vessels","route":"/pathways/angiogenic-switch/"}]}}