Regulatory approval

Published by the Food and Drug Administration. Approved

ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase). Limitations of Use: ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.

This is written in the approval document.

Citation

Takeda Pharmaceuticals America, Inc. Iclusig (ponatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203469s037lbl.pdf. Revised March 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)	ABL1 p.T315I, BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Ponatinib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2016-11-28	Food and Drug Administration	Indication received traditional approval.