Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that ABL1 p.T315I and BCR::ABL1 status confers therapeutic sensitivity to Ponatinib in patients with Chronic Myeloid Leukemia, BCR-ABL1+.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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. Takeda Pharmaceuticals America, Inc. Iclusig (ponatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s022lbl.pdf. Revised November 2016. Accessed October 6, 2026.

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.