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In the context of Vemurafenib & Melanoma (cutaneous) (BRAF m), in August 2011, the FDA granted approval for vemurafenib. This approval was specifically for the treatment of unresectable or metastatic Melanoma (cutaneous) (BRAF m), which must be identified using an FDA-approved test, initially the cobas® 4800 BRAF V600 Mutation Test. The decision to approve was supported by the results of BRIM‑3, a phase III clinical trial (1, 2, 3).
The European Medicines Agency granted marketing authorization for vemurafenib for adults with BRAF V600 mutation-…