Genentech melanoma drug, Roche companion diagnostic win FDA approval

A groundbreaking drug-diagnostic combination for metastatic melanoma patients was approved by federal regulators, nearly two months before approval was expected.
Zelboraf, developed by Berkeley’s Plexxikon Inc. and marketed by South San Francisco’s Genentech Inc. , will treat patients with the deadly skin cancer who have a specific mutation, known as BRAF V600E. That mutation, found only in cancerous tumors and in a vast majority of malignant melanomas, is detected in a test developed by Roche Molecular Diagnostics of Pleasanton.