Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Nilotinib in patients with Chronic Myelogenous Leukemia.
The European Medicines Agency (EMA) has authorized nilotinib for the treatment of adult and pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia (CML) in the chronic phase.
This statement is based on a regulatory approval from the European Medicines Agency:
Tasigna is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase.