Ariad Pharmaceuticals, Inc., today 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 (TKI) therapy is not appropriate, including CML or Ph+ ALL that is T315I mutation positive, or where there is prior TKI resistance or intolerance.
“Patients with CML or Ph+ ALL can become resistant to their therapies over time,” said Professor Jeffrey Lipton, Ph.D., M.D., staff physician at The Princess Margaret Cancer Centre and one of the PACE trial investigators. “Iclusig will be a valuable new therapeutic option in Canada for patients with refractory CML and Ph+ ALL, where we have a proven unmet medical need.”
Iclusig is approved under the Notice of Compliance with Conditions (NOC/c) policy based on promising evidence of clinical effectiveness following review by Health Canada. Products approved under this policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness, and have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. In addition, these products either respond to a serious unmet medical need in Canada or have demonstrated a significant improvement in the benefit/risk profile over existing therapies.
For more details, go to: http://investor.ariad.com/phoenix.zhtml?c=118422&p=irol-newsArticle&ID=2032274&highlight=