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 chronic phase, accelerated phase, and blast phase Ph+ CML previously treated with one or more tyrosine kinase inhibitors and for whom imatinib, nilotinib, and dasatinib are no 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 patients with CP, 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.