Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ABL1 p.T315I status confers therapeutic sensitivity to Ponatinib in patients with Chronic Myelogenous Leukemia.
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.
This statement is based on a regulatory approval from the European Medicines Agency:
Iclusig is indicated in adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (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.