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The drug that started the targeted therapy era in 2001, turning chronic myeloid leukaemia into a manageable condition with near-normal life expectancy.
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.
ATP-competitive inhibitor of ABL, KIT, PDGFR. Connects to KIT.
1.Oral drug is absorbed and reaches the tumour
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). Generic imatinib since 2016; often under $100 a month with insurance and far below the Gleevec price.
Multi-source generic on low-cost tiers; usually no prior authorisation. Cash prices without insurance are modest. Brand Gleevec is usually excluded in favour of the generic.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA70 · SMC advice: imatinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
CML in blast crisis, accelerated phase, or in chronic phase after failure of of interferon-alpha
Chronic myeloid leukaemia: first targeted kinase inhibitor, approved in under 3 months source
KIT (CD117) positive unresectable and/or metastatic GIST
KIT+ gastrointestinal stromal tumour source
Newly diagnosed adults with Philadelphia chromosome positive CML
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Pediatric patients with recurrent PH+ chronic phase CML after stem cell transplant or who are resistant to interferon alpha therapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
CML in blast crisis, accelerated phase, or in chronic phase after failure of of interferon-alpha
Confirmed: the accelerated approval of 2001 converted to traditional approval 2.6 years after it was granted.
Newly diagnosed Philadelphia positive CML in pediatric patients
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Pediatric patients with recurrent PH+ chronic phase CML after stem cell transplant or who are resistant to interferon alpha therapy
Confirmed: the accelerated approval of 2003 converted to traditional approval 3.4 years after it was granted.
KIT (CD117) positive unresectable and/or metastatic GIST
Confirmed: the accelerated approval of 2002 converted to traditional approval 6.7 years after it was granted.
Adjuvant treatment of adults following complete gross resection of KIT (CD117) positive gastrointestinal stromal tumors (GIST)
Adjuvant GIST source
Newly diagnosed adults with Philadelphia chromosome positive CML
Confirmed: the accelerated approval of 2002 converted to traditional approval 6.4 years after it was granted.
Newly diagnosed Philadelphia positive CML in pediatric patients
Confirmed: the accelerated approval of 2006 converted to traditional approval 4.5 years after it was granted.
Adjuvant treatment of adults following complete gross resection of KIT (CD117) positive gastrointestinal stromal tumors (GIST)
Confirmed: the accelerated approval of 2008 converted to traditional approval 3.1 years after it was granted.
First US generic imatinib launched source
| Region | Year | Indication |
|---|---|---|
| US | 2001 | Chronic myeloid leukaemia |
| US | 2002 | KIT+ GIST |
| Adverse event |
|---|
| Oedema |
| Nausea |
| Muscle cramps |
| Diarrhoea |
| Rash |
| Fatigue |
| Neutropenia |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United Statesgeneric | Medicare Part D; generic since 2016 (list price fell >90%) | not disclosed | - |
| United Kingdomgeneric | NHS standard; generic | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Sunitinib remains the standard second-line treatment, with ripretinib as a better-tolerated alternative, and mutation-guided choice by circulating tumour DNA is being tested prospectively in INSIGHT.
Dasatinib is preferred over imatinib for paediatric Ph-positive ALL in many protocols because of its central nervous system penetration and superior outcomes in this trial.
Continuous imatinib from induction lets many children with Philadelphia-positive ALL avoid transplant, but the intensive BFM backbone is toxic; later trials reduced chemotherapy intensity under tyrosine kinase inhibitor cover.
Regorafenib is the standard third-line treatment for GIST after imatinib and sunitinib.
KIT testing is worthwhile in mucosal and acral melanoma, and imatinib is a guideline option for exon 11 or 13 mutations after or alongside immunotherapy.
Together with AALL0031, EsPhALL established kinase inhibitor plus chemotherapy as standard for paediatric Ph-positive ALL, with later trials giving imatinib continuously and reducing transplant.
Three years of adjuvant imatinib is standard for high-risk resected GIST with imatinib-sensitive mutations; longer courses are being tested.
Imatinib is the standard systemic treatment for unresectable, recurrent or metastatic dermatofibrosarcoma protuberans and is used neoadjuvantly to shrink large tumours before surgery.
Query for this drug: (TITLE:"Imatinib" OR ABSTRACT:"Imatinib" OR TITLE:"Gleevec" OR ABSTRACT:"Gleevec" OR TITLE:"STI571" OR ABSTRACT:"STI571" OR TITLE:"STI-571" OR ABSTRACT:"STI-571" OR TITLE:"Glivec" OR ABSTRACT:"Glivec") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Imatinib, not a curated reading list.
Shares Dasatinib versus imatinib with chemotherapy for paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (CCCG-ALL-2015), DASISION, A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP, Sokal and ELTS risk scores (chronic myeloid leukaemia).
Shares A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP, Seoul St. Mary's Hospital, Sokal and ELTS risk scores (chronic myeloid leukaemia), BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR).
Shares A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP, Sokal and ELTS risk scores (chronic myeloid leukaemia), Ph-positive ALL, BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR).
Shares PhALLCON, Ph-positive ALL, BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR), BCR::ABL1 kinase domain mutations (T315I and others).
Shares Sunitinib in advanced gastrointestinal stromal tumour after failure of imatinib, GRID: regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib, INTRIGUE: ripretinib versus sunitinib in advanced gastrointestinal stromal tumour after imatinib, PDGFRB.
Shares Stephen P. Hunger, Hagop M. Kantarjian, Ph-positive ALL, Mixed-phenotype acute leukaemia.
Shares A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP, Sokal and ELTS risk scores (chronic myeloid leukaemia), BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR), BCR::ABL1 kinase domain mutations (T315I and others).
Shares KIT D816V, PDGFRA exon 18 mutation (D842V), GIST risk stratification (mitotic count, size, site; Miettinen and modified NIH criteria), PDGFRA D842V-mutant GIST.