Bosulif (bosutinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Pfizer Europe MA EEIG. Bosulif (bosutinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/bosulif-epar-product-information_en.pdf. Revised August 2025. Accessed August 29, 2025.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
Bosulif is indicated for the treatment of adult and paediatric patients aged 6 years and older with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).	2
Bosulif is indicated for the treatment of 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.	2
Bosulif is indicated for the treatment of 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.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Bosutinib
Sensitivity (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Bosutinib
Sensitivity (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Bosutinib
Sensitivity (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Bosutinib
Sensitivity (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Bosutinib
Sensitivity (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Bosutinib