Bosutinib

Bosutinib is indicated for the treatment of adult patients with: • newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML). • CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

Reddy–Bosutinib (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 14 CLINICAL TRIALS).

• 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 14 CLINICAL TRIALS). Reddy-Bosutinib 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.

Bosulif is indicated for the treatment of:  Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).  Adult and paediatric patients aged 6 years and older with CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

 Adult patients with accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.