Summary basis of decision for ARZERRA™

Health Canada has issued a Notice of Compliance with conditions under the Notice of Compliance with Conditions (NOC/c) Policy to GlaxoSmithKline Inc., for the drug product, Arzerra. The product was authorized under the NOC/c Policy on the basis of the promising nature of the clinical evidence, and the need for confirmatory studies to verify the clinical benefit. Patients should be advised of the fact that the market authorization was issued with conditions. Arzerra contains the medicinal ingredient ofatumumab, which is an antineoplastic agent. Ofatumumab is a recombinant human monoclonal antibody (IgG1κ) that binds specifically to the CD20 molecule expressed on B lymphocytes. Binding of Arzerra to the CD20 molecule induces tumour cell death. Read more here.