Indications of Ponatinib

Iclusig is indicated for the treatment of adult patients with:

• Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.

• Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated.

• T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive  Ph+ ALL.

Limitations of Use: Iclusig is not indicated and is not recommended for the treatment of patients with  newly diagnosed CP-CML.

FDA,2022.02