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 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.
This statement is based on a regulatory approval from the European Medicines Agency:
Iclusig is indicated as monotherapy in paediatric 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.