Summary basis of decision for Zelboraf

Health Canada has issued a Notice of Compliance to Hoffmann-La Roche Limited for the drug product, Zelboraf. Zelboraf contains the medicinal ingredient vemurafenib which is a kinase inhibitor that slows down or stops the growth of melanoma tumour cells expressing mutated BRAF V600 proteins. BRAF is mutated in approximately half of patients with advanced melanomas. Zelboraf is indicated as a monotherapy for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. A validated test is required to identify BRAF V600 mutation status. Read the full document here.