Summary Basis of Decision (SBD) for Perjeta

Health Canada has issued a Notice of Compliance to Hoffmann-La Roche Limited for the drug product, Perjeta. Perjeta (pertuzumab) is a recombinant humanized monoclonal antibody based upon the human IgG1(κ) framework sequence and is a first-in-class human epidermal growth factor receptor 2 (HER2) dimerization inhibitor. Based on Health Canada's review, the benefit/risk profile of Perjeta in combination with Herceptin (trastuzumab) and docetaxel is favourable for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Read more here.