Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Imatinib in patients with Chronic Myelogenous Leukemia.
The European Medicines Agency (EMA) has authorized imatinib for the treatment of adult and pediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.
This statement is based on a regulatory approval from the European Medicines Agency:
Glivec is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.