Vemurafenib, an oral inhibitor of some mutated forms of the BRAF serine threonine kinase, was recently approved for the treatment of patients with unresectable or metastatic melanoma with the BRAF V600E mutation as detected by an FDA- approved test. It is not recommended for use in patients with wild-type BRAF melanoma. The clinical trial supporting approval of vemurafenib (PLX4032) was performed in treatment-naïve patients with the V600E mutation as detected by the Cobas 4800 BRAF V600 Mutation Test. About 40%-60% of cutaneous melanomas have BRAF mutations that result in constitutive activation of downstream signaling through the MAPK pathway; about 90% of those carry the V600E mutation.
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