Summary Basis of Decision (SBD) for ERIVEDGE

Health Canada has issued a Notice of Compliance to Hoffmann-La Roche Limited for the drug product, Erivedge. 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 Erivedge is favourable for the treatment of adult patients with histologically confirmed metastatic basal cell carcinoma or locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy. Read more here.