Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Nilotinib

Contributions

Date	Contributor	Description
2025-06-26	Van Allen lab	Resolving statements mapped to incorrect propositions
2024-10-30	Van Allen lab	Initial access of FDA approvals
2007-10-29	Food and Drug Administration	Indication received traditional approval.