OnCo
drugsProductNot mapped hereapproved

Bosutinib

Bosutinib is a CML pill with less cardiovascular and pleural toxicity than its rivals; its main side effect is diarrhoea.

Approved 2012 for resistant/intolerant CML and 2017 first line (BFORE). Preferred for patients with cardiovascular risk (versus nilotinib/ponatinib) or pleural effusion risk (versus dasatinib). Was the comparator arm in ASCEMBL, which established asciminib.

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Bosutinib
PubChem
Modality
Small-molecule BCR-ABL1/SRC TKI
Mechanism
Dual SRC/ABL inhibitor active against most imatinib-resistant BCR-ABL1 mutations except T315I and V299L.
Brand / code
Bosulif
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).

Commercial insurance
step therapy common

Generic imatinib first is common; Bosulif otherwise covered with prior authorisation.

Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.

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 TA401 · 2016SMC: accepted
Appraised for
CML after prior TKI when imatinib, nilotinib and dasatinib are not appropriate
Notes
Untreated CML appraised 2018; check NICE.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA401 · SMC advice: bosutinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2012Ph+ CML after prior TKI
US2017Newly diagnosed Ph+ CML chronic phase
EU2013Ph+ CML

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
33 studies2 recruiting28 Phase 25 Phase 3
Search “Bosutinib” 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
Bosutinib
intervention: Bosutinib
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Bosutinib" OR ABSTRACT:"Bosutinib" OR TITLE:"Bosulif" OR ABSTRACT:"Bosulif") 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 Bosutinib, not a curated reading list.

Connected

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