FDA Approves Test That Can Detect Faulty Gene in NSCLC
FDA: Test Approved to Detect Faulty Gene in Some Lung CA
(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% of cases of non-small-cell lung cancer (NSCLC).
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 news release.
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% of lung cancers are NSCLC, the FDA said.
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 for those 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.