Therapeutic Response

ABL1 p.T315I and BCR::ABL1 status confers therapeutic sensitivity to Ponatinib in patients with Chronic Myeloid Leukemia, BCR-ABL1+.

Statements

Source and description
Iclusig (ponatinib) [package insert]. FDA. 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.
Iclusig (ponatinib) [product monograph]. HC. Health Canada approved ponatinib for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) who are not appropriate for other tyrosine kinase inhibitor (TKI) therapy, including those with the T315I mutation or prior TKI resistance or intolerance.