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 adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in the chronic phase.
This statement is based on a regulatory approval from the European Medicines Agency:
SPRYCEL is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.