Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Bosutinib in patients with Chronic Myelogenous Leukemia.

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.