Summary Basis of Decision (SBD) for KADCYLA

Health Canada has issued a Notice of Compliance to Hoffmann-La Roche Limitedfor the drug product Kadcyla. Based on Health Canada's review, the benefit/risk profile of Kadcyla is favourable as a single agent for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive, metastatic breast cancer who received both prior treatment with Herceptin (trastuzumab) and a taxane, separately or in combination. Patients should have either received prior therapy for metastatic disease, or developed disease recurrence during or within 6 months of completing adjuvant therapy. Read more here.