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.

The European Medicines Agency (EMA) has authorized bosutinib as for the treatment of adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).

This statement is based on a regulatory approval from the European Medicines Agency:

Bosulif is indicated for the treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).

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.