Regulatory approval

Published by the Health Canada. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	BCR::ABL1	Chronic Myelogenous Leukemia	Nilotinib
HC (1)	BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Nilotinib