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CHMP Recommends EU Approval of Roche PGx Drug Zelboraf


The European Commission's Committee for Medicinal Products for Human Use last eek recommended marketing authorization for Roche's Zelboraf as a monotherapy for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

Zelboraf (vemurafenib) inhibits BRAF proteins that harbor a mutation at position 600, which causes cell proliferation in the absence of growth factors that would normally be required for proliferation.

"The benefits with Zelboraf are its ability to improve overall survival in melanoma patients that have tumors that are positive for BRAF V600E," CHMP said in a statement.

The committee, "on the basis of quality, safety and efficacy data submitted, considers there to be a favorable benefit-to-risk balance for Zelboraf and therefore recommends the granting of the marketing authorization," it added.

The European Commission will now decide whether to grant marketing authorization for the drug in Europe. Roche said it expects a decision by February 2012.

CHMP recommended that "a pharmacovigilance plan for Zelboraf will be implemented as part of the marketing authorization."

In August, the US Food and Drug Administration approved the drug and Roche's companion BRAF V600 diagnostic for use in the US market (PGx Reporter 8/17/2011).

Roche's Cobas 4800 BRAF V600 Mutation Test is already CE-marked in the EU.

Roche said that it has also filed marketing authorization submissions for Zelboraf in Australia, New Zealand, Brazil, India, Mexico, Canada and other countries worldwide.

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