Tasigna (nilotinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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).
TASIGNA (nilotinib) 150mg and 200mg capsules are indicated for the treatment of pediatric patients 2 years of age and older with newly diagnosed Ph+ CML-CP.
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.
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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)