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Iclusig FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 25, 2021.

FDA Approved: Yes (First approved December 14, 2012)
Brand name: Iclusig
Generic name: ponatinib
Dosage form: Tablets
Company: Ariad Pharmaceuticals, Inc.
Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia

Iclusig (ponatinib) 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.
  • 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.

Development timeline for Iclusig

Dec 18, 2020Approval FDA Approves Supplemental New Drug Application for Takeda‚Äôs Iclusig (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML
Dec 14, 2012Approval FDA Approves Iclusig to Treat Two Rare Types of Leukemia
Oct 24, 2012ARIAD Announces U.S. Food and Drug Administration Acceptance of NDA Filing for Ponatinib
Aug 13, 2012Ariad Announces Submission of New Drug Application for Ponatinib to the U.S. Food and Drug Administration

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.