Pharma regulator Health Canada has approved the use of US drugmaker Ariad Pharmaceuticals’ (Nasdaq: ARIA) 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, staff physician at The Princess Margaret Cancer Centre, Canada, and one of the PACE trial investigators, adding: “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.”
Marketing approval under NOC/c policy
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