Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Dasatinib in patients with Chronic Myelogenous Leukemia.
The European Medicines Agency (EMA) has authorized dasatinib (anhydrous) for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in the chronic phase (Ph+ CML-CP) or Ph+CML-CP with resistant or intolerant to prior therapy including imatinib.
This statement is based on a regulatory approval from the European Medicines Agency:
SPRYCEL is indicated for the treatment of paediatric patients with newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.