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February 21, 2012

EC Clears Roche, Plexxikon’s Zelboraf for BRAF V600-Mutated Melanoma

  • The European Commission approved Roche and Plexxikon’s melanoma drug Zelboraf (vemurafenib) for the treatment of BRAF V600-mutation positive unresectable or metastatic disease. Roche’s cobas 4800 BRAF V600 mutation test, which is used to identify patients suitable for Zelboraf therapy, has already been granted a CE mark in the EU. Zelboraf and the companion cobas test were approved in the U.S. in 2011, and approvals have been granted or filed in other territories globally.

    Zelboraf is an oral small molecule kinase inhibitor. Approval of the drug in the EU was based on data from the 675-patient Phase III BRIM3 trial, which demonstrated that in comparison with standard first-line dacarbazine chemotherapy, use of Zelboraf to treat BRAF V600 mutation-positive metastatic melanoma reduced the risk of death by 63%. A subsequent post hoc analysis after longer follow-up also showed that the kinase inhibitor boosted overall survival from 9.6 months to 13.2 months. The cobas 4800 BRAF V600 mutation test was validated through the BRIM3 trial and open-label Phase II BRIM2 study.

    Zelboraf is being developed under 2006 license and collaboration agreement between Roche and Plexxikon, which is part of Daiichi Sankyo. The drug is being co-promoted in the U.S. by Daiichi Sankyo and Genentech. Roche and Genentech are progressing a broad development program for the drug as monotherapy and combination therapy in a number of tumor types.

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