Summary Basis of Decision (SBD) for Tafinlar

Health Canada has issued a Notice of Compliance to GlaxoSmithKline Inc. for the drug product, Tafinlar. 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 Tafinlar is favourable as a monotherapy for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation. A validated test is required to identify BRAF V600 mutation status. Read more here.