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News » Filed under: Skin Cancer - Melanoma

FDA Approves Zelboraf for Melanoma

Article date: August 18, 2011

By Stacy Simon

The US Food and Drug Administration (FDA) has approved the drug Zelboraf (vemurafenib) for some people with melanoma that has spread to other parts of the body, or can’t be removed by surgery. It’s only been tested for melanoma patients who have a gene mutation called BRAF V600E.

In an international trial, 675 patients with late-stage melanoma received either Zelboraf or another cancer drug called dacarbazine. All the patients had the BRAF V600E mutation and had not received prior therapy. For patients in the dacarbazine group, the median survival time after treatment was 8 months, with 64% still living. Median survival time has still not been reached for patients in the Zelboraf group, with 77% still living.

The FDA approved Zelboraf on an accelerated 6-month schedule because few other treatment options are available. It also approved a first-of-a-kind test called the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic that will help determine if a patient’s melanoma cells have the BRAF V600E mutation. The BRAF protein is normally involved in regulating cell growth, but is mutated in about half of the patients with late-stage melanomas. Zelboraf works by blocking the function of the V600E-mutated BRAF protein.

The most common side effects reported in patients receiving Zelboraf included joint pain, rash, hair loss, fatigue, nausea, and skin sensitivity when exposed to the sun. About 26% of patients developed another type of skin cancer called cutaneous squamous cell carcinoma, which was treated with surgery. Patients treated with Zelboraf should avoid sun exposure.

The drug is marketed by South San Francisco based-Genentech, a member of the Roche Group.

Reviewed by: Members of the ACS Medical Content Staff


ACS News Center stories are provided as a source of cancer-related news and are not intended to be used as press releases.

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