Regulatory approval

Published by the Health Canada.

Health Canada approved nilotinib for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).

This is written in the approval document as:

TASIGNA (nilotinib) 150 mg and 200 mg capsules are indicated for The treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).

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.

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Therapeutic response

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

Type Biomarker(s) Cancer type Therapy(ies)