Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Imatinib in patients with Chronic Myeloid Leukemia, BCR-ABL1+.
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.