Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized bosutinib as for the treatment of adult patients with accelerated phase, and blast phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitors and for whom imatinib, nilotinib, and dasatinib are not considered appropriate treatment options.

This is written in the approval document as:

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.

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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Bosutinib

Contributions

Date	Contributor	Description
2025-08-29	Van Allen lab	On 2025-08-26, the EMA published an EPAR - Assessment report - Variation that revised indications for Bosulif (bosutinib) to support pediatric patients with chronic phase Ph+ CML.
2025-06-02	European Medicines Agency	Indication received approval from the European Commission.
2024-10-20	Van Allen lab	Adding EMA approvals for use to database