Therapeutic Response

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

Statements

Source and description
Tasigna (nilotinib) [product monograph]. HC.

Health Canada approved nilotinib for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
Tasigna (nilotinib) [product monograph]. HC.

Health Canada approved tasigna for the treatment of the treatment of pediatric patients 2 years of age and older with newly diagnosed Ph+ CML-CP.
Tasigna (nilotinib) [product monograph]. HC.

Health Canada approved nilotinib for The treatment of chronic phase (CP) and accelerated phase (AP) Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib
Tasigna (nilotinib) [product monograph]. HC.

Health Canada approved nilotinib for the treatment of pediatric patients 2 years of age and older with Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib.
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.