What are the treatment regimens for bosutinib (Bosulif) in the treatment of chronic myelogenous leukemia (CML)?

Updated: Oct 23, 2019
  • Author: Rossa Khalaf, MD; Chief Editor: Emmanuel C Besa, MD  more...
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Bosutinib (Bosulif), a second-generation TKI,  is a dual Src and ABL kinase inhibitor. It is approved for chronic-, accelerated-, or blast-phase Ph+ CML in patients resistant to or intolerant of other therapies, including imatinib, dasatinib, or nilotinib, but is not for use in cases with the T315I mutation. [23]   FDA also gave accelerated approval for newly diagnosed chronic-phase  Philadelphia chromosome–positive chronic myelogenous leukemia (Ph+ CML). [24, 25]

Bosutinib dose:

  • Newly-diagnosed chronic-phase Ph+ CML (accelerated approval): 400 mg PO daily with food
  • Chronic-, progressive, or blast-phase Ph+ CML with resistance or intolerance to prior therapy: 500 mg PO daily with food

Dose escalation is allowed in patients with Ph+ CML who did not achieve or maintain a hematologic, cytogenetic, or molecular response and did not have ≥grade 3 adverse reactions at the recommended starting dose; the dose may be increased by 100-mg increments once daily; not to exceed 600 mg/day.

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