Zelboraf (Daiichi Sankyo/Roche) is EU approved for BRAFV600 mutation Metastatic Melanoma

Plexxikon Inc., a member of Daiichi Sankyo Group,has announced that the European Commission has approved Zelboraf (vemurafenib) for the monotherapy treatment of adult patients with BRAFV600 mutation-positive unresectable or Metastatic Melanoma. The cobas 4800 BRAF V600 Mutation Test, a companion diagnostic used to identify patients with the BRAF mutation, is CE marked and commercially available in Europe. Zelboraf is designed to selectively inhibit the BRAF mutation that occurs in about half of all cases of melanoma. Zelboraf and its companion diagnostic have already been approved in the United States, Switzerland, Israel, Brazil, New Zealand and Canada. In the United States, Zelboraf is being co-promoted by Daiichi Sankyo, Inc. and Genentech, a member of the Roche Group. Roche promotes Zelboraf outside of the United States.