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23 Feb 2012

EU Approves Skin Cancer Medicine Zelboraf

Zelboraf (vemurafenib), manufactured by Roche, has been approved by the European Commission, for treating patients with BRAF V600 mutationpositive unresectable or metastatic melanoma.

The European Commission has approved Roche’s Zelboraf (vemurafenib) as a monotherapy for the treatment of adult patients with BRAF V600 mutationpositive unresectable or metastatic melanoma, the most aggressive form of skin cancer.

 

Zelboraf is designed to target and inhibit mutated forms of the BRAF protein found in about half of all cases of melanoma.

 

In pivotal clinical trials, Zelboraf is the only treatment to benefit patient survival in both previously untreated and previously treated people with advanced melanoma who tested positive for BRAF V600 mutations using the Roche cobas 4800 BRAF V600 Mutation Test.

 

In 2011, Zelboraf became the first and only US FDA

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