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Table 1 General information on anti-cancer TKI

From: Clinical pharmacology of tyrosine kinase inhibitors becoming generic drugs: the regulatory perspective

Tyrosine kinase inhibitor (INN) Branded name Market Authorization Holder (MAH) Target tyrosine kinases Indication(s) European birth date CMA Orphan designation
Bosutinib Bosulif® Pfizer BCR-ABL,SRC Patients with CML for which Imatinib, Nilotinib, and Dasatinib are not appropriate 27th March 2013 Yes CML
Dasatinib Sprycel® Bristol-Myers Squibb BCR-ABL CML 23th December 2005 No CML, ALL
Erlotinib Tarceva® Hoffman-La Roche EGFR NSCLC, pancreatic cancer 19th September 2005 No No
Gefitinib Iressa® Astra Zeneca EGFR NSCLC in carriers of activating EGFR-mutations 24th June 2010 No No
Imatinib Glivec® Novartis BCR-ABL, KIT, PDGFR-A, PDGFR-B CML, GIST, BCR-ABL- positive ALL, dermatofibrosarcoma protuberans, myeloproliferative neoplasms, hypereosinophilic syndromes 7th of November 2001 No Expired and withdrawn
Lapatinib Tyverb® Glaxo Smith Kline ERBB2 (HER-2) HER-2 positive breast cancer 10th June 2008 Yes No
Nilotinib1 Tasigna® Novartis BCR-ABL, KIT,PDGFR-A, PDGFR-B CML 19th November 2007 No CML
Pazopanib Votrient® Glaxo Smith Kline VEGFR, PDGFR, KIT Renal cell carcinoma, STS 14th June 2010 No Withdrawn
Ponatinib2 Iclusig® Ariad BCR-ABL Patients with CML for which Imatinib, Nilotinib, and Dasatinib are not appropriate (or patients carrying a T315I single-point-mutation) 1st July 2013   CML, ALL
Sorafenib Nexavar® Bayer VEGFR-2,VEGFR-3 Renal cell carcinoma, hepatocellular carcinoma 19th July 2006 No Renal cell carcinoma, Hepatocellular carcinoma
Sunitinib Sutent® Pfizer VEGFR 1-3, PDGFR-A, PDGFR-B; KIT, FLT3 Renal cell carcinoma, GIST, pNET 19th July 2006 Initially, then full approval Withdrawn
  1. ALL, acute lymphatic leukemia; CML, chronic myeloid leukemia ; CMA, Conditional Marketing Authorization (none of the above mentioned is currently authorized under exceptional circumstances, according to European Medicines Agency (EMA) website accessed in Sept 2013 [15]); GIST, gastrointestinal stromal tumor; MA, Marketing Authorization; MAH, Marketing Authorization Holder; NSCLC, non-small cell lung cancer; pNET, pancreatic neuroendocrine tumors; STS, soft tissue sarcoma; 1Nilotinib is similar to Imatinib according to the orphan regulation; 2US-Food and Drug Administration (FDA) asked the manufacturer of Ponatinib to suspend marketing due to the risk of life-threatening blood clots and severe narrowing of blood vessels; source of information: European Public Assessment Reports (EPARs) of the above mentioned TKI [15].