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 Republic of Ireland's Health Service Executive (HSE) has approved ponatinib for reimbursement as a monotherapy treatment option 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, nilotinib, and bosutinib 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 Health Service Executive:
Treatment of 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, nilotinib and bosutinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.