FDA Grants Full Approval to Iclusig for Leukemia Indications

ARIAD announced that the Food and Drug Administration (FDA) has fully approved Iclusig (ponatinib)

ARIAD announced that the Food and Drug Administration (FDA) has fully approved Iclusig (ponatinib) for the following indications:

  • treatment of adults with chronic phase (CP), accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated
  • treatment of adults with with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL

Iclusig, a kinase inhibitor, was granted accelerated approval in December 2012 that allowed patients earlier access to the drug based on a surrogate clinical endpoint. During this time, the Company conducted more studies to confirm the clinical benefit of Iclusig. Iclusig was also granted an Orphan Drug Designation by the FDA because it was intended to treat a rare disease or condition. 

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The FDA’s full approval and label update was supported by 48-month follow-up data from the Phase 2 PACE clinical trial that involved heavily pre-treated patients with resistant or intolerant CML or Ph+ ALL. Updated data on the CP-CML patients (n=270) from the current trial showed that at a minimum follow-up of 48 months (as of August 3, 2015), 110 patients continued to receive treatment with ponatinib. A key finding was that 55% of CP-CML patients achieved major cytogenetic response (MCyR)—the primary endpoint—at any time. Also, 39% of patients achieved a major molecular response (MMR) at any time. 

A randomized, dose-ranging postmarketing study, OPTIC (Optimizing Ponatinib Treatment in CML) is being conducted to better understand the optimal dose for Iclusig. This trial is enrolling patients with CP-CML who are resistant to at least two approved TKIs.

Iclusig is available as 15mg, 30mg, and 45mg strength tablets.

For more information call (855) 552-7423 or visit Iclusig.com.