{"entity":{"id":"imatinib","kind":"drug","name":"Imatinib","aka":["STI571","STI-571","Glivec"],"tldr":"The drug that started the targeted therapy era in 2001, turning chronic myeloid leukaemia into a manageable condition with near-normal life expectancy.","summary":"Imatinib is an ATP-competitive inhibitor of the ABL, KIT and PDGFR kinases, taken as 400 mg once daily in chronic-phase CML and as adjuvant therapy for GIST, with 600-800 mg for advanced disease. Approved in 2001 for chronic myeloid leukaemia and 2002 for KIT-positive gastrointestinal stromal tumours, it started the targeted therapy era: in IRIS, 10-year overall survival was about 83%, turning CML into a manageable condition with near-normal life expectancy. Three years of adjuvant imatinib is standard after high-risk GIST resection, and it is also used in rare kinase-driven tumours. It is now generic. Resistance mutations such as T315I led to later ABL inhibitors, and whether patients in deep remission can stop safely is an active question. For a newcomer: the proof that a cancer could be switched off by blocking one enzyme.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Imatinib","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Imatinib"}],"tags":[],"related":["american-ginseng-fatigue","st-johns-wort-interaction","kit-d816v","bcr-abl1-transcript"],"cancers":["sarcoma","cll","cml-chronic-phase","gist-kit-exon-11","all-paediatric-ph-positive","dermatofibrosarcoma-protuberans","mucosal-melanoma","acral-melanoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["kit"],"drugs":[],"companies":["novartis","natco"],"institutions":[],"pathways":["bcr-abl1-signalling"],"terms":[],"trials":["nct07406633","nct04971226","nct03459534"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Gleevec","modality":"Small-molecule kinase inhibitor (BCR-ABL, KIT, PDGFRA)","mechanism":"ATP-competitive inhibitor of ABL, KIT, PDGFR.","approvals":[{"region":"US","year":2001,"indication":"Chronic myeloid leukaemia"},{"region":"US","year":2002,"indication":"KIT+ GIST"}],"mechanismSteps":["Oral drug is absorbed and reaches the tumour","Binds the ATP pocket (or allosteric site) of BCR-ABL, KIT, and PDGFRA","Phosphorylation of downstream substrates stops","Binds the inactive kinase conformation; CML cells lose their sole driver","Oncogene-addicted cells arrest and undergo apoptosis"],"dosing":{"route":"Oral","schedule":"400 mg once daily (chronic-phase CML, GIST adjuvant 3 years); 600-800 mg for advanced disease","modifications":"Hold for grade 3 neutropenia or hepatotoxicity","monitoring":"Blood counts, LFTs, BCR-ABL PCR every 3 months in CML, fluid retention","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},"toxicity":[{"event":"Oedema"},{"event":"Nausea"},{"event":"Muscle cramps"},{"event":"Diarrhoea"},{"event":"Rash"},{"event":"Fatigue"},{"event":"Neutropenia"}],"access":[{"country":"US","reimbursement":"Medicare Part D; generic since 2016 (list price fell >90%)","generic":true,"source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NHS standard; generic","generic":true,"asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2001-05-10","type":"accelerated-approval","region":"US","note":"Chronic myeloid leukaemia: first targeted kinase inhibitor, approved in under 3 months","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"CML in blast crisis, accelerated phase, or in chronic phase after failure of of interferon-alpha"},{"date":"2002-02-01","type":"accelerated-approval","region":"US","note":"KIT+ gastrointestinal stromal 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chronic phase after failure of of interferon-alpha"},{"date":"2006-09-27","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Newly diagnosed Philadelphia positive CML in pediatric patients"},{"date":"2006-09-27","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2003 converted to traditional approval 3.4 years after it was granted.","indication":"Pediatric patients with recurrent PH+ chronic phase CML after stem cell transplant or who are resistant to interferon alpha therapy"},{"date":"2008-09-26","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2002 converted to traditional approval 6.7 years after it was granted.","indication":"KIT (CD117) positive unresectable and/or metastatic GIST"},{"date":"2008-12-19","type":"accelerated-approval","region":"US","note":"Adjuvant GIST","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Adjuvant treatment of adults following complete gross resection of KIT (CD117) positive gastrointestinal stromal tumors (GIST)"},{"date":"2009-05-27","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2002 converted to traditional approval 6.4 years after it was granted.","indication":"Newly diagnosed adults with Philadelphia chromosome positive CML"},{"date":"2011-04-01","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2006 converted to traditional approval 4.5 years after it was granted.","indication":"Newly diagnosed Philadelphia positive CML in pediatric patients"},{"date":"2012-01-31","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2008 converted to traditional approval 3.1 years after it was granted.","indication":"Adjuvant treatment of adults following complete gross resection of KIT (CD117) positive gastrointestinal stromal tumors (GIST)"},{"date":"2016-02-01","type":"approval","region":"US","note":"First US generic imatinib launched","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/imatinib/","neighbours":{"technology":[{"id":"american-ginseng-fatigue","kind":"technology","name":"American ginseng for cancer-related fatigue","route":"/technologies/american-ginseng-fatigue/"},{"id":"oral-solid-dose-manufacturing","kind":"technology","name":"Oral solid dose manufacturing (tablets and capsules)","route":"/technologies/oral-solid-dose-manufacturing/"},{"id":"small-molecule-api-synthesis","kind":"technology","name":"Small-molecule API synthesis","route":"/technologies/small-molecule-api-synthesis/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase 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