Bosutinib

Bosutinib (Bosulif, Pfizer Europe MA EEIG) has 3 EU-approved indications in 1 tumour type. Each needs a biomarker result: BCR::ABL1 (3).
Approved indications of Bosutinib
Biomarker requirementRegimenSettingConditions
Chronic myeloid leukaemia3
Philadelphia chromosome / BCR::ABL1 translocation
Monotherapy
1L
Chronic phase only; Aged 6 years and older
Philadelphia chromosome / BCR::ABL1 translocation
Monotherapy
2L
Chronic phase only; Previously treated with one or more tyrosine kinase inhibitor(s); Aged 6 years and older; imatinib, nilotinib and dasatinib are not considered appropriate treatment options
Philadelphia chromosome / BCR::ABL1 translocation
Monotherapy
2L
Accelerated or blast phase only; Previously treated with one or more tyrosine kinase inhibitor(s); Imatinib, nilotinib and dasatinib are not considered appropriate treatment options
Full text of section 4.1 (therapeutic indications)

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.

Label history

32 changes to the Bosulif label since 2014, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes