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Imatinib

The drug that started the targeted therapy era in 2001, turning chronic myeloid leukaemia into a manageable condition with near-normal life expectancy.

CML (IRIS: 10-year OS ~83%), GIST (adjuvant 3 years), and rare kinase-driven tumours. Now generic. The proof that a cancer could be switched off by blocking one enzyme.

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Imatinib
PubChem
Mechanism, step by step
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1.Oral drug is absorbed and reaches the tumour

Modality
Small-molecule kinase inhibitor (BCR-ABL, KIT, PDGFRA)
Mechanism
ATP-competitive inhibitor of ABL, KIT, PDGFR.
Brand / code
Gleevec
Dosing & schedule
Route
Oral
Schedule
400 mg once daily (chronic-phase CML, GIST adjuvant 3 years); 600-800 mg for advanced disease
Dose modifications
Hold for grade 3 neutropenia or hepatotoxicity
Monitoring
Blood counts, LFTs, BCR-ABL PCR every 3 months in CML, fluid retention

Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.

Medicare
Part D (self-administered)

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.

Commercial insurance
covered on label

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.

NICE recommendedNICE TA70 · 2003SMC: accepted
Appraised for
Chronic phase CML (first-line)
Notes
Unresectable or metastatic KIT-positive GIST: TA86 (2004). Adjuvant GIST: TA326 (2014). Generic since 2017; now costs the NHS a small fraction of the original price.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA70 · SMC advice: imatinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 10 May 2001ApprovalUS

    Chronic myeloid leukaemia: first targeted kinase inhibitor, approved in under 3 months source

  2. 1 Feb 2002ApprovalUS

    KIT+ gastrointestinal stromal tumour source

  3. 19 Dec 2008ApprovalUS

    Adjuvant GIST source

  4. 1 Feb 2016ApprovalUS

    First US generic imatinib launched source

Approvals

RegionYearIndication
US2001Chronic myeloid leukaemia
US2002KIT+ GIST

Safety

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Toxicity profile
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.

Cost & access

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Cost & access
CountryReimbursement
United StatesgenericMedicare Part D; generic since 2016 (list price fell >90%)
United KingdomgenericNHS standard; generic

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
530 studies8 recruiting77 Phase 224 Phase 3
Search “Imatinib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Imatinib
intervention: Imatinib
Open on ClinicalTrials.gov →

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Key papers

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Latest papers

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Literature trend610 papers in the last 12 months-3% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Imatinib" OR ABSTRACT:"Imatinib" OR TITLE:"Gleevec" OR ABSTRACT:"Gleevec") 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.

Connected

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Pages like this

not linked directly; found by shared links

cancers

6

technologies

1

targets

3

companies

1

institutions

4

pathways

2

terms

9

trials

2

ideas

10

people

8

bottlenecks

3

key papers

2