FDA expands use of Tarceva, approves companion Dx from Roche

05/15/2013 | Medscape (free registration) · Fox Business

The FDA approved Roche Holding's cobas EGFR Mutation Test as a companion diagnostic for Tarceva, or erlotinib, a nonsmall-cell lung cancer drug developed by Roche's Genentech unit. The test, designed to determine which patients will benefit from Tarceva, is the first FDA-approved companion diagnostic that can detect epidermal growth factor receptor mutations found in around 10% of nonsmall-cell lung cancer. The FDA also approved the use of Tarceva as a first-line treatment for patients with metastasized NSCLC who carry the specific gene mutation.

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Medscape (free registration) · Fox Business

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