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BOSULIF®Indications and Usage (bosutinib)

1 INDICATIONS AND USAGE

BOSULIF is indicated for the treatment of adult patients with:

  • Newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). This indication is approved under accelerated approval based on molecular and cytogenetic response rates [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and confirmation of clinical benefit in an ongoing long-term follow up trial.
  • Chronic phase, accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy.
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