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Bosutinib is a CML pill with less cardiovascular and pleural toxicity than its rivals; its main side effect is diarrhoea.
Bosutinib is a dual SRC/ABL tyrosine kinase inhibitor for Philadelphia-chromosome-positive chronic myeloid leukaemia, active against most imatinib-resistant BCR-ABL1 mutations except T315I and V299L. It was approved in 2012 for CML after prior TKI therapy (EU 2013) and in 2017 for newly diagnosed chronic-phase disease after the BFORE trial. Its niche is defined by what it avoids: it is preferred for patients with cardiovascular risk, where nilotinib and ponatinib carry arterial occlusive risk, and for those at risk of pleural effusion with dasatinib. Diarrhoea is its main side effect, usually early and manageable, along with liver enzyme rises. It served as the comparator arm in ASCEMBL, the trial that established asciminib in later-line CML, and where it sits against asciminib is now the open question. For a newcomer: a CML pill chosen for the side effects it does not cause.
Dual SRC/ABL inhibitor active against most imatinib-resistant BCR-ABL1 mutations except T315I and V299L. Connects to BCR::ABL1 (Philadelphia chromosome).
1.Bosutinib slips into a pocket on BCR::ABL1 (Philadelphia chromosome).
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.
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 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.
Sources: NICE TA401 · SMC advice: bosutinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Adults with newly diagnosed chronic phase Philadelphia chromosome positive CML
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Adults with newly diagnosed chronic phase Philadelphia chromosome positive CML
Confirmed: the accelerated approval of 2017 converted to traditional approval 3.4 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| US | 2012 | Ph+ CML after prior TKI |
| US | 2017 | Newly diagnosed Ph+ CML chronic phase |
| EU | 2013 | Ph+ CML |
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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.
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 LYN kinase, HCK kinase, SRC family kinases, A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP.
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 BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR), BCR::ABL1 kinase domain mutations (T315I and others), Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia, accelerated and blast phase.
Shares BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (KEGG map), Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia, accelerated and blast phase.
Shares BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR), BCR::ABL1 kinase domain mutations (T315I and others), BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (KEGG map).
Shares Sokal and ELTS risk scores (chronic myeloid leukaemia), BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR), BCR::ABL1 kinase domain mutations (T315I and others), Chronic myeloid leukaemia, chronic phase.
Shares Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia, accelerated and blast phase, BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).