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 Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukemia (CML) in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
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 Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.