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Ariad Pharmaceuticals Inc Announces Accelerated Approval by FDA of Iclusig for Patients with CML and Ph+ ALL Resistant or Intolerant to Prior Tyrosine Kinase Inhibitor Therapy


Friday, 14 Dec 2012 12:47pm EST 

Ariad Pharmaceuticals Inc announced that following a priority review, the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Iclusig (ponatinib) for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy. The FDA approval of Iclusig was based on results from the pivotal Phase 2 PACE (Ponatinib Ph+ ALL and CML Evaluation) trial in patients with CML or Ph+ ALL who were resistant or intolerant to prior TKI therapy, or who had the T315I mutation of BCR-ABL. Iclusig had robust anti-leukemic activity, with 54% of chronic-phase CML patients, including 70% of patients with the T315I mutation, achieving a major cytogenetic response (MCyR) - the primary endpoint of the PACE trial for chronic-phase patients. 

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31 Jul 2014