# Bosutinib

Source: https://onco.cc/drugs/bosutinib/  
OnCo record `bosutinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-08
- Tags: gap-fill
- Brand: Bosulif
- Modality: Small-molecule BCR-ABL1/SRC TKI
- Mechanism: Dual SRC/ABL inhibitor active against most imatinib-resistant BCR-ABL1 mutations except T315I and V299L.
- Approvals: US 2012: Ph+ CML after prior TKI; US 2017: Newly diagnosed Ph+ CML chronic phase; EU 2013: Ph+ CML

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Bosutinib
- Label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=bosutinib

## Connected records

- cancers: [Chronic myeloid leukaemia (CML)](https://onco.cc/cancers/cml/), [Chronic myeloid leukaemia, accelerated and blast phase](https://onco.cc/cancers/cml-advanced-phase/), [Chronic myeloid leukaemia, chronic phase](https://onco.cc/cancers/cml-chronic-phase/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [BCR::ABL1 (Philadelphia chromosome)](https://onco.cc/targets/bcr-abl/), [HCK kinase](https://onco.cc/targets/hck/), [LYN kinase](https://onco.cc/targets/lyn/), [SRC family kinases](https://onco.cc/targets/src/)
- companies: [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)
- trials: [A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP](https://onco.cc/trials/nct04971226/), [TAPUR (Targeted Agent and Profiling Utilization Registry)](https://onco.cc/trials/tapur/)
- pathways: [BCR::ABL1 (Philadelphia chromosome)](https://onco.cc/pathways/bcr-abl1-signalling/), [Chronic myeloid leukaemia (KEGG map)](https://onco.cc/pathways/cml-signalling/)
- terms: [BCR::ABL1 kinase domain mutations (T315I and others)](https://onco.cc/terms/abl1-kinase-domain-mutations/), [Sokal and ELTS risk scores (chronic myeloid leukaemia)](https://onco.cc/terms/sokal-elts-scores/)
- biomarkers: [BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR)](https://onco.cc/biomarkers/bcr-abl1-transcript/)

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