Tasigna (nilotinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Novartis Pharmaceuticals Corporation. Tasigna (nilotinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022068s041lbl.pdf. Revised February 2024. Accessed October 30, 2024.

Regulatory approvals

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

Indication	Statements
Tasigna is a kinase inhibitor indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.	2
Tasigna is a kinase inhibitor indicated for the treatment of adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.	2
Tasigna is a kinase inhibitor indicated for the treatment of pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
FDA (3)	BCR::ABL1	Chronic Myelogenous Leukemia	Nilotinib
FDA (3)	BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Nilotinib