Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Ponatinib in patients with Acute Lymphoid Leukemia.
The European Medicines Agency (EMA) has authorized ponatinib for the treatment of adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I variant.
This statement is based on a regulatory approval from the European Medicines Agency:
Iclusig is indicated in adult patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.