Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to ponatinib for the treatment of adult patients with T315I-positive chronic myeloid leukemia (CML) in chronic phase, accelerated phase, or blast phase. The product label states the following limitations of use: ponatinib is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.

This is written in the approval document as:

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.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ABL1 p.T315I	Chronic Myelogenous Leukemia	Ponatinib