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.

Iclusig is a kinase inhibitor indicated for the:...Treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

Regimens for relapsed or refractory Ph-positive ALL…ponatinib is a treatment option for patients with a T315I mutation and/or for patients for whom no other TKI is indicated.

...c) Disease status: (i) For non -US sites: participants who have relapsed (post 0 or 1 HSCT) or are resistant or intolerant to at least one prior therapy that contained a BCR-ABL-targeted tyrosine kinase inhibitor (TKI), or for US sites: participants who have relapsed (post 0 or 1 HSCT) or are resistant or intolerant to at least one prior therapy that contained a second-generation BCR-ABL1-targeted TKI (i.e, dasatinib, nilotinib, and bosutinib); OR (ii) Have a BCR-ABL1 T315I mutation irrespective of relapse, resistance/intolerance, or transplant status and irrespective of any prior TKI use. ...

Among patients with accelerated-phase CML, 55% (95% CI, 44 to 66) had a major hematologic response by 6 months (the primary end point). A major cytogenetic response was seen in 39%, 24% had a complete cytogenetic response, and 16% had a major molecular response....High response rates were observed among patients with BCR-ABL mutations, including those with the T315I mutation, and among those without BCR-ABL mutations...ponatinib showed clinically significant activity in patients with CML and those with Ph-positive ALL.