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FDA Approves Diagnostic Test for Lung Cancer

New use for Tarceva (erlotinib) also approved (May 14)

The FDA has approved the cobas EGFR Mutation Test (Roche Molecular Systems), a companion diagnostic for the cancer drug Tarceva (erlotinib; Genentech/OSI Pharmaceuticals). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10% of non–small-cell lung cancer (NSCLC).

The test was approved with an expanded use for Tarceva as a first-line treatment for patients with metastatic NSCLC who have certain mutations in the EGFR gene.

Lung cancer is the leading cause of cancer-related death among men and women. According to the National Cancer Institute, an estimated 228,190 new cases of lung cancer will occur this year, with 159,480 deaths. About 85% of lung cancers are NSCLC, making it the most common type of lung cancer.

The safety and effectiveness of the cobas EGFR Mutation Test were demonstrated by clinical data, which showed that, on average, NSCLC patients with specific types of EGFR mutations (exon 19 deletions or exon 21 L858R substitution mutations) survived without disease progression for 10.4 months when they received erlotinib, compared with 5.4 months for those who received a standard two-drug chemotherapy regimen. The investigators used tumor samples from the clinical trial to validate the test’s use in this patient population.

The approval is the fourth indication for Tarceva (erlotinib) and the third use for lung cancer. The FDA approved the drug in April 2010 for maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. Tarceva was originally approved in November 2004 for the treatment of patients with locally advanced or metastatic NSCLC after the failure of at least one prior chemotherapy regimen.

Source: FDA; May 14, 2013.

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