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 pediatric patients 2 years of age and older with Ph+ CML-CP with resistance or intolerance to 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 pediatric patients 2 years of age and older with Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib.