Summary Basis of Decision (SBD) for Bosulif

Health Canada has issued a Notice of Compliance under the Notice of Compliance with Conditions (NOC/c) Guidance to Pfizer Canada Inc. for the drug product, Bosulif. Based on Health Canada's review, the benefit/risk profile of Bosulif is favourable for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy, and for whom subsequent treatment with imatinib, nilotinib and dasatinib is not clinically appropriate. Read more here.