Therapeutic Response

BCR::ABL1 status confers therapeutic sensitivity to Nilotinib in patients with Chronic Myeloid Leukemia, BCR-ABL1+.

Statements

Source and description
Tasigna (nilotinib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to nilotinib for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
Tasigna (nilotinib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to nilotinib for the treatment of adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.
Tasigna (nilotinib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to nilotinib for the treatment of pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.
Tasigna (nilotinib) [product information]. EMA. 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.
Tasigna (nilotinib) [product information]. EMA. The European Medicines Agency (EMA) has authorized nilotinib for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy including imatinib. Nilotinib's product information further states that efficacy data in patients with CML in blast crisis are not available.
Tasigna (nilotinib) [product information]. EMA. The European Medicines Agency (EMA) has authorized nilotinib for the treatment of pediatric patients with chronic phase Phildelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.