The European Medicines Agency review of vemurafenib (Zelboraf®) for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.

doi:10.1016/j.ejca.2013.01.015

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The European Medicines Agency review of vemurafenib (Zelboraf®) for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.

European journal of cancer (Oxford, England : 1990) - 1 May 2013

da Rocha Dias Silvy, Salmonson Tomas, van Zwieten-Boot Barbara, Jonsson Bertil, Marchetti Serena, Schellens Jan H M, Giuliani Rosa, Pignatti Francesco

Abstract excerpt

The applicant company Roche Registration Ltd. submitted to the European Medicines Agency (EMA) an application for marketing authorisation for vemurafenib. Vemurafenib is a low molecular weight, orally available, inhibitor of oncogenic V600 BRAF serine-threonine kinase. Mutations in the BRAF gene which substitute the valine at amino acid position 600 constitutively activate BRAF proteins, which will drive cell...

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PMID: 23481513
DOI: 10.1016/j.ejca.2013.01.015

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