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FDA Approves Vemurafenib for Advanced Melanoma


 

Vemurafenib will be marketed as Zelboraf by Roche, which announced submission of applications for approval in the United States and Europe on May 11. Roche’s Genentech has a comarketing agreement with vemurafenib developer Plexxikon, a member of Daiichi Sankyo.

In June, Roche and Bristol-Meyers Squibb (maker of ipilimumab), announced that they would collaborate on a phase I/II study to determine whether combining the two drugs is safe and effective in patients with BRAF mutations.

The cobas 4800 BRAF V600 Mutation Test is manufactured by Roche Molecular Systems in Pleasanton, Calif.

Genentech sponsored the BRIM-2 and BRIM-3 trials. Dr. Chapman reported consultant/advisory roles and research funding from its parent company Roche. Some coauthors were Roche employees, and others reported similar relationships with Genentech. Dr. Ribas and several of his coauthors reported similar consulting and advisory relationships with Roche/Genentech. Dr. Menzies had no relevant financial conflicts of interest.

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