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 and pediatric patients aged 6 years and older 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 and paediatric patients aged 6 years and older with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).