What is the generic name?

PONATINIB HYDROCHLORIDE

What is the Trade Name for PONATINIB HYDROCHLORIDE?

Iclusig

What are the Indications for PONATINIB HYDROCHLORIDE?

• 1 INDICATIONS AND USAGE 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. Iclusig is a kinase inhibitor 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. ( 1 ) 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. ( 1 ) T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL. ( 1 ) Limitations of Use : Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML. ( 5.7 ) Limitations of Use : Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML [see Warnings and Precautions (5.7) ] .

References: https://open.fda.gov/