BOSULIF (bosutinib) is indicated for the treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML).
Market authorization in patients with newly-diagnosed chronic phase Ph+ CML is based on major molecular response (MMR) rates in a Phase 3 clinical trial with a minimum of 12 months of follow-up (see CLINICAL TRIALS).
BOSULIF (bosutinib) is indicated for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior TKI therapy.
Market authorization in patients with resistance or intolerance to prior TKI therapy, is based on cytogenetic and hematologic response rates observed in a single-arm, Phase 1/ 2 study. Overall survival benefit has not been demonstrated (see CLINICAL TRIALS).
BOSULIF should only be prescribed by a qualified healthcare professional who is experienced in the use of antineoplastic therapy and in the treatment of chronic myeloid leukemia.
Geriatrics (≥ 65 years of age): No clinically relevant age-related pharmacokinetic differences have been observed in the elderly.Pediatrics (< 18 years of age): The safety and efficacy of BOSULIF in patients less than 18 years of age have not been evaluated. No data are available.