Regulatory approval

Published by the Health Canada. Approved

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 is written in the approval document as:

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.

Therapeutic response

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

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

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals