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ARIAD Pharma Reports Approval Of Iclusig In Canada - Quick Facts

ARIAD Pharmaceuticals Inc. (ARIA) announced that Health Canada has approved the use of Iclusig (as ponatinib hydrochloride) in Canada for the treatment of adult patients with all phases of chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom other tyrosine kinase inhibitor or TKI therapy is not appropriate, including CML or Ph+ ALL that is T315I mutation positive, or where there is prior TKI resistance or intolerance.

Iclusig will be made available through a controlled distribution program. Under this program, prescribers who have completed the certification procedure are able to prescribe Iclusig. Trained pharmacies will verify the prescriber's certified status prior to dispensing Iclusig to the patient.

The Health Canada decision was based on two-year data from the pivotal Phase 2 PACE 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 demonstrated anti-leukemic activity, achieving a major cytogenetic response (MCyR) in 56 percent of chronic-phase CML patients and in 70 percent of patients with the T315I mutation. MCyR within the first 12 months of treatment was the primary endpoint of the PACE trial for chronic-phase patients.

In patients with advanced disease, 57 percent of accelerated-phase CML patients and 31 percent of blast-phase CML patients achieved a major hematologic response (MaHR) with Iclusig. MaHR within the first 6 months was the primary endpoint in the trial for patients with advanced disease. In patients with Ph+ ALL, 41 percent achieved MaHR.

ARIAD's upcoming dose-ranging trial to evaluate three starting doses of Iclusig in patients with refractory, chronic-phase CML who are resistant to at least two approved TKIs -- planned to begin in mid-2015 -- will serve as the confirmatory trial for the Health Canada approval.

CML is a cancer of the white blood cells that according to the Chronic Myelogenous Leukemia Society of Canada affects 1 in 100,000, with about 5,500 Canadians living with the disease.

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