Brand Name

Iclusig

Generic Name
Ponatinib
View Brand Information
FDA approval date: December 14, 2012
Classification: Kinase Inhibitor
Form: Tablet

What is Iclusig (Ponatinib)?

ICLUSIG ® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Newly diagnosed Ph+ ALL in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease -negative complete remission at the end of induction. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial. As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. Chronic Myeloid Leukemia Chronic phase CML with resistance or intolerance to at least two prior kinase inhibitors. Accelerated phase or blast phase CML for whom no other kinase inhibitors are indicated. T315I-positive CML . ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Newly diagnosed Ph+ ALL, in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease -negative complete remission at the end of induction. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial. As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. Chronic Myeloid Leukemia Chronic phase CML with resistance or intolerance to at least two prior kinase inhibitors. Accelerated phase or blast phase CML for whom no other kinase inhibitors are indicated. T315I-positive CML . Limitations of Use : ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.
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