BRAF mutation testing algorithm for vemurafenib treatment in melanoma: recommendations from an expert panel


  • Funding sources
    Succinct Healthcare Communications provided logistical support in setting up the focus group, and provided medical writing support, both of which were facilitated by a grant from Roche Products Ltd. Editorial control was retained by the authors.

  • Conflicts of interest
    D.G.dC., A.W. and P.T. have been paid as advisors to Roche, and their laboratories are sponsored by Roche to provideBRAFtesting. L.F. has received honoraria from Roche to act as an advisor and to speak at congresses. A.W. has received honoraria from Roche, Astra-Zeneca and Pfizer to act in an advisory capacity. P.N. has received honoraria from Roche, GlaxoSmithKline and Bristol-Myers Squibb to act in an advisory capacity and to present at congresses. E.B. has received honoraria from Roche to act in an advisory capacity. J.M. and C.H. have received honoraria from Roche to act in an advisory capacity for an unrelated product.

David Gonzalez de Castro.


The incidence of melanoma has increased rapidly over the past 30 years, and the disease is now the sixth most common cancer among men and women in the U.K. Many patients are diagnosed with or develop metastatic disease, and survival is substantially reduced in these patients. Mutations in the BRAF gene have been identified as key drivers of melanoma cells and are found in around 50% of cutaneous melanomas. Vemurafenib (Zelboraf®; Roche Molecular Systems Inc., Pleasanton, CA, U.S.A.) is the first licensed inhibitor of mutated BRAF, and offers a new first-line option for patients with unresectable or metastatic melanoma who harbour BRAF mutations. Vemurafenib was developed in conjunction with a companion diagnostic, the cobas® 4800 BRAF V600 Mutation Test. The purpose of this paper is to make evidence-based recommendations to facilitate the implementation of BRAF mutation testing and targeted therapy in patients with metastatic melanoma in the U.K. The recommendations are the result of a meeting of an expert panel and have been reviewed by melanoma specialists and representatives of the National Cancer Research Network Clinical Study Group on behalf of the wider melanoma community. This article is intended to be a starting point for practical advice and recommendations, which will no doubt be updated as we gain further experience in personalizing therapy for patients with melanoma.