Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Nilotinib in patients with Chronic Myeloid Leukemia, BCR-ABL1+.

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.

Citation

Novartis Pharmaceuticals Canada Inc. Tasigna (nilotinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00076372.PDF. Revised July 2024. Accessed June 2025.