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 information]. EMA. The European Medicines Agency (EMA) has authorized ponatinib for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the p.T315I variant.
Iclusig (ponatinib) [product information]. EMA. The European Medicines Agency (EMA) has authorized ponatinib as a monotherapy for the treatment of pediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.