Summary Basis of Decision (SBD) for Xofigo

Health Canada has issued a Notice of Compliance to Bayer Inc. for the radiopharmaceutical product Xofigo. The market authorization was based on quality (chemistry and manufacturing), non-clinical (pharmacology and toxicology), and clinical (pharmacology, safety, and efficacy) information submitted. Based on Health Canada's review, the benefit/risk profile of Xofigo is favourable for the treatment of patients with castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease. Read more here.