-- Scott Roberts
THURSDAY, May 16 (HealthDay News) -- The U.S. Food and Drug
Administration has approved a test designed to detect a faulty gene
that's present in about 10 percent of cases of non-small cell lung
The cobas EGFR Mutation Test, a companion diagnostic to the
approved cancer drug Tarceva (erlotinib), detects a mutation in the
epidermal growth factor receptor (EGFR) gene, the FDA said in a
Lung cancer is the leading cause of cancer-related death for
both men and women, accounting for about 228,000 annual cases in
the United States. Some 85 percent of lung cancers are NSCLC, the
In approving the new diagnostic, the FDA also sanctioned
expanded use for Tarceva as a first-line treatment for people with
NSCLC that has spread to other parts of the body and who have the
mutated gene, the agency said.
The new diagnostic is produced by California-based Roche
Molecular Systems. Tarceva, first approved in 2004, now has three
approvals for lung cancer. It's produced by California-based
Genentech and New York-based OSI Pharmaceuticals.
The U.S. National Cancer Institute has more about
non-small cell lung cancer.
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