Drug name (generic) | Bosutinib monohydrate (BOSULIF®) |
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Phase (for indication under discussion) | Bosutinib has been studied for its safety and efficacy in patients with Philadelphia chromosome positive (Ph+) leukemia with resistance or intolerance to prior tyrosine kinase inhibitor therapy. |
Indication (specific to discussion) | Bosutinib is currentlyFDA approved and indicated for the treatment of chronic, accelerated, or blast phase Ph+ chronic myeloid leukemia in adult patients with resistance or intolerance to prior therapy. |
Pharmacology description/mechanism of action | Dual Abl/Src tyrosine kinase inhibitor |
Route of administration | BOSULIF ® tablets are orally administered, available in two strengths, 100mg or 500mg tablets. |
Chemical structure | C26H29Cl2N5O3 ∙ H2O (monohydrate) (Image taken from rxlist.com) |
Pivotal trial(s) | Study 200, BELA Trial 32 |