Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Bosutinib in patients with Chronic Myeloid Leukemia, BCR-ABL1+.

The European Medicines Agency (EMA) has authorized bosutinib as for the treatment of adult and pediatric patients aged 6 years and older with chronic 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 statement is based on a regulatory approval from the European Medicines Agency:

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.

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.

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.