Difference between revisions of "Nintedanib (Vargatef)"

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
m (Text replacement - "http://www.thelancet.com" to "https://www.thelancet.com")
m
 
(19 intermediate revisions by 3 users not shown)
Line 1: Line 1:
=Mechanism of action=
+
==Mechanism of action==
From the [https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=504524 NCI Drug Dictionary]: An orally bioavailable, indolinone-derived, receptor tyrosine kinase (RTK) inhibitor with potential antiangiogenic and antineoplastic activities. Multitargeted tyrosine kinase inhibitor BIBF 1120 selectively binds to and inhibits vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet-derived growth factor receptor (PDGFR) tyrosine kinases, which may result in the induction of endothelial cell apoptosis; a reduction in tumor vasculature; and the inhibition of tumor cell proliferation and migration. In addition, this agent also inhibits members of the Src family of tyrosine kinases, including Src, Lck, Lyn, and FLT-3 (fms-like tyrosine kinase 3).
+
From the [https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=504524 NCI Drug Dictionary]: An orally bioavailable, indolinone-derived, receptor tyrosine kinase (RTK) inhibitor with potential antiangiogenic and antineoplastic activities. Multitargeted tyrosine kinase inhibitor BIBF 1120 selectively binds to and inhibits vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet-derived growth factor receptor (PDGFR) tyrosine kinases, which may result in the induction of endothelial cell apoptosis; a reduction in tumor vasculature; and the inhibition of tumor cell proliferation and migration. In addition, this agent also inhibits members of the Src family of tyrosine kinases, including Src, Lck, Lyn, and FLT-3 (fms-like tyrosine kinase 3).<ref name="insert">[https://pro.boehringer-ingelheim.com/products/vargatef/sites/default/files/2021-07/vargatef-epar-product-information_en.pdf Nintedanib (Vargatef) package insert]</ref><ref>[[:File:Nintedanib.pdf | Nintedanib (Vargatef) package insert (locally hosted backup)]]</ref><ref>[https://pro.boehringer-ingelheim.com/products/vargatef/ Vargatef manufacturer's website]</ref>
  
=Preliminary data=
+
==Diseases for which it is established==
==[[Mesothelioma]]==
+
*[[Non-small cell lung cancer, nonsquamous]]
* Grosso F, Steele N, Novello S, Nowak AK, Popat S, Greillier L, John T, Leighl NB, Reck M, Taylor P, Planchard D, Sørensen JB, Socinski MA, von Wangenheim U, Loembé AB, Barrueco J, Morsli N, Scagliotti G. Nintedanib plus pemetrexed/cisplatin in patients with malignant pleural mesothelioma: Phase II results from the randomized, placebo-controlled LUME-Meso trial. J Clin Oncol. 2017 Nov 1;35(31):3591-3600. Epub 2017 Sep 11. [http://ascopubs.org/doi/full/10.1200/JCO.2017.72.9012 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/28892431 PubMed]
+
==Diseases for which it is used==
 +
*[[Non-small cell lung cancer]]
 +
*[[Ovarian cancer]]
  
==[[Non-small cell lung cancer]]==
+
==Patient drug information==
* Reck M, Kaiser R, Mellemgaard A, Douillard JY, Orlov S, Krzakowski M, von Pawel J, Gottfried M, Bondarenko I, Liao M, Gann CN, Barrueco J, Gaschler-Markefski B, Novello S; LUME-Lung 1 Study Group. Docetaxel plus nintedanib versus docetaxel plus placebo in patients with previously treated non-small-cell lung cancer (LUME-Lung 1): a phase 3, double-blind, randomised controlled trial. Lancet Oncol. 2014 Feb;15(2):143-55. 2. Epub 2014 Jan 9. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70586-2/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/24411639 PubMed]
+
*[https://pro.boehringer-ingelheim.com/products/vargatef/sites/default/files/2021-07/vargatef-epar-product-information_en.pdf Nintedanib (Vargatef) package insert]<ref>[https://pro.boehringer-ingelheim.com/products/vargatef/sites/default/files/2021-07/vargatef-epar-product-information_en.pdf Nintedanib (Vargatef) package insert]</ref>
* Hanna NH, Kaiser R, Sullivan RN, Aren OR, Ahn MJ, Tiangco B, Voccia I, Pawel JV, Kovcin V, Agulnik J, Gaschler-Markefski B, Barrueco J, Sikken P, Schloss C, Kim JH; LUME-Lung 2 Study group. Nintedanib plus pemetrexed versus placebo plus pemetrexed in patients with relapsed or refractory, advanced non-small cell lung cancer (LUME-Lung 2): A randomized, double-blind, phase III trial. Lung Cancer. 2016 Dec;102:65-73. Epub 2016 Oct 27. [http://www.sciencedirect.com/science/article/pii/S0169500216305104 link to SD article] [https://www.ncbi.nlm.nih.gov/pubmed/27987591 PubMed]
+
*[https://www.uptodate.com/contents/nintedanib-patient-drug-information Nintedanib (Vargatef) patient drug information (UpToDate)]<ref>[https://www.uptodate.com/contents/nintedanib-patient-drug-information Nintedanib (Vargatef) patient drug information (UpToDate)]</ref>
  
==[[Ovarian cancer]]==
+
==History of changes in EMA indication==
* du Bois A, Kristensen G, Ray-Coquard I, Reuss A, Pignata S, Colombo N, Denison U, Vergote I, Del Campo JM, Ottevanger P, Heubner M, Minarik T, Sevin E, de Gregorio N, Bidziński M, Pfisterer J, Malander S, Hilpert F, Mirza MR, Scambia G, Meier W, Nicoletto MO, Bjørge L, Lortholary A, Sailer MO, Merger M, Harter P; AGO Study Group led Gynecologic Cancer Intergroup/European Network of Gynaecologic Oncology Trials Groups Intergroup Consortium. Standard first-line chemotherapy with or without nintedanib for advanced ovarian cancer (AGO-OVAR 12): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2016 Jan;17(1):78-89. Epub 2015 Nov 16. [http://www.sciencedirect.com/science/article/pii/S1470204515003666 link to SD article] [https://www.ncbi.nlm.nih.gov/pubmed/26590673 PubMed]
+
*2014-11-21: Initial marketing authorization as Vargatef. 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, nonsquamous|non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology]] after first line chemotherapy. ''(Based on LUME-Lung 1)''
  
[[Category:Drug index]]
+
==Also known as==
 +
*'''Code name:''' BIBF-1120
 +
*'''Brand names:''' Cyendiv, Idofnib, Nifev, Nindanib, Nintena, Nintenib, Nintib, Ofev, Vargatef
 +
 
 +
==References==
 +
<references/>
 +
 
 +
[[Category:Drugs]]
 
[[Category:Oral medications]]
 
[[Category:Oral medications]]
  
[[Category:Kinase inhibitors]]
 
 
[[Category:VEGFR inhibitors]]
 
[[Category:VEGFR inhibitors]]
 
[[Category:FGFR inhibitors]]
 
[[Category:FGFR inhibitors]]
Line 22: Line 30:
 
[[Category:SRC inhibitors]]
 
[[Category:SRC inhibitors]]
  
[[Category:Investigational]]
+
[[Category:Non-small cell lung cancer medications]]
 +
[[Category:Non-small cell lung cancer, nonsquamous medications]]
 +
[[Category:Ovarian cancer medications]]
 +
 
 +
[[Category:EMA approved in 2014]]

Latest revision as of 10:51, 11 September 2023

Mechanism of action

From the NCI Drug Dictionary: An orally bioavailable, indolinone-derived, receptor tyrosine kinase (RTK) inhibitor with potential antiangiogenic and antineoplastic activities. Multitargeted tyrosine kinase inhibitor BIBF 1120 selectively binds to and inhibits vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet-derived growth factor receptor (PDGFR) tyrosine kinases, which may result in the induction of endothelial cell apoptosis; a reduction in tumor vasculature; and the inhibition of tumor cell proliferation and migration. In addition, this agent also inhibits members of the Src family of tyrosine kinases, including Src, Lck, Lyn, and FLT-3 (fms-like tyrosine kinase 3).[1][2][3]

Diseases for which it is established

Diseases for which it is used

Patient drug information

History of changes in EMA indication

Also known as

  • Code name: BIBF-1120
  • Brand names: Cyendiv, Idofnib, Nifev, Nindanib, Nintena, Nintenib, Nintib, Ofev, Vargatef

References