Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized bosutinib as for the treatment of adult patients with chronic phase, accelerated phase, and blast phase Ph+ CML previously treated with one or more tyrosine kinase inhibitors and for whom imatinib, nilotinib, and dasatinib are no considered appropriate treatment options.

This is written in the approval document as:

Bosulif is indicated for the treatment of adult patients with 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.

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 May 2023. Accessed March 11, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

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