FDA Approves Roche's Companion Dx and Drug for Melanoma | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved Roche's drug and companion diagnostic test for late-stage unresectable melanoma.

The agency today approved Zelboraf (vemurafenib), co-developed with Daiichi Sankyo, for the treatment of patients with melanoma whose tumors express a gene mutation known as BRAF V600E. At the same time it approved the cobas 4800 BRAF V600 Mutation Test for determining whether a patient's melanoma cells have the mutation.

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