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18-08-2011 | Dermatology | Article

US FDA approve vemurafenib for treatment of BRAF gene V600-positive melanoma

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MedWire News: The US Food and Drug Administration (FDA) have approved the personalized medicine vemurafenib and its accompanying genetic test for treatment of metastatic melanoma patients who are positive for the BRAF V600 mutation.

The decision was based on the results of a single international trial of 675 treatment-naïve patients with late-stage melanoma with the BRAF V600 mutation, in which the patients received treatment with vemurafenib or dacarbazine, an alternative melanoma treatment.

In the trial, vemurafenib was more effective at prolonging survival than dacarbazine, with 77% of vemurafenib versus 64% of dacarbazine-treated patients still living today.

Due to the limited number of treatment options for late-stage melanoma, vemurafenib and the accompanying "first-of-a-kind" cobas 4800 BRAF V600 Mutation Test are being reviewed as part of the FDA's 6-month priority-review program, which includes "drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists."

They are both being approved ahead of their review completion dates of October 28, 2011 and November 12, 2011, respectively.

Richard Padzur (US FDA Center for Drug Evaluation and Research) explained that this has been a good year for patients with metastatic melanoma, as this is the second new treatment to be approved.

Ipilimumab was approved in March 2011 for treatment of metastatic melanoma following positive results from a randomized trial, as reported by MedWire News.

"The FDA approval of Zelboraf (vemurafenib) marks a major step forward in personalizing the treatment of metastatic melanoma, a devastating disease that until this year had limited approved treatment options," said Hal Barron, Chief Medical Officer and Head of Global Product Development for Roche, who developed the drug.

"We will continue to study this medicine with a goal of further improving outcomes for people with melanoma and other cancers that are driven by BRAF mutations."

Alberto Gutierrez from the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health commented: "Today's approval of Zelboraf and the cobas test is a great example of how companion diagnostics can be developed and used to ensure patients are exposed to highly effective, more personalized therapies in a safe manner."

MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2011

By Helen Albert

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