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.
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
This statement is based on a regulatory approval from the Health Canada:
TASIGNA (nilotinib) 150 mg and 200 mg capsules are indicated 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.