The targeted therapy Zelboraf™ (vemurafenib) has been approved by the US Food and Drug Administration (FDA) for the treatment of melanomas that carry a common mutation in the BRAF gene.

Of the more than one million new diagnoses of skin cancer each year, roughly 68,000 involve melanoma. More than 8,000 people die of melanoma each year in the United States. What makes melanoma so dangerous is that it is more likely than other types of skin cancer to spread (metastasize) to other parts of the body.

In order to provide more individualized and more effective cancer therapy, much research has been focused on determining specific pathways involved in cancer cell growth or survival. The BRAF gene is known to play a part in cell growth, and mutations in BRAF are common in several types of cancer. Approximately half of all late-stage melanomas carry a specific BRAF mutation known as V600E. Zelboraf blocks the function of the protein produced by this mutated gene and inhibits cell growth.

To evaluate Zelboraf in the treatment of advanced melanoma, researchers conducted a Phase III clinical trial among 675 patients with previously untreated, inoperable, Stage IIIC or Stage IV melanoma. The study was restricted to patients with a V600E mutation in the BRAF gene. Study participants were treated with either Zelboraf or the chemotherapy drug dacarbazine. Patients treated with Zelboraf had better progression-free and overall survival. The most common side effects of Zelboraf were joint pain, rash, hair loss, fatigue, photosensitivity, and nausea.

Based on these and other results, the FDA approved Zelboraf for the treatment of patients with unresectable (cannot be surgically removed) or metastatic melanoma that carries the V600E mutation of BRAF.

A test to detect the V600E mutation (the cobas® 4800 BRAF V600 Mutation Test) was approved at the same time as Zelboraf. Testing is necessary prior to treatment with Zelboraf. Zelboraf is not recommended for the treatment of melanomas that lack the V600E BRAF mutation.

Reference: US Food and Drug Administration. FDA news release. FDA approves Zelboraf and companion diagnostic test for late-stage skin cancer. August 17, 2011.

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