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FDA NEWS RELEASE

For Immediate Release: May 14, 2013
Media Inquiries: Susan Laine, 301-796-5349, susan.laine@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA 

FDA approves first companion diagnostic to detect gene mutation associated with a type of lung cancer

New use for Tarceva also approved
 
The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC).
 
The test is being approved with an expanded use for Tarceva as a first-line treatment for patients with NSCLC that has spread to other parts of the body (metastasized) and 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, there will be an estimated 228,190 new cases of lung cancer this year, and 159,480 deaths. About 85 percent of lung cancers are NSCLC, making it the most common type of lung cancer.
 
“The approval of the cobas EGFR Mutation Test will allow physicians to identify non-small cell lung cancer patients who are candidates for receiving Tarceva as first line therapy,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient.”  
 
The safety and effectiveness of the cobas EGFR Mutation Test was established with clinical data showing that, on average, NSCLC patients with specific types of EGFR mutations (exon 19 deletions or exon 21 L858R substitution mutations) lived without their disease progressing for 10.4 months when they received Tarceva treatment, compared to 5.4 months for those who received a standard two-drug chemotherapy regimen. Investigators used tumor samples from the clinical trial to validate the test’s use in this patient population.
 
The approval is Tarceva’s fourth indication and the third use for lung cancer. The FDA approved Tarceva on April 16, 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 failure of at least one prior chemotherapy regimen.
 
The cobas EGFR Mutation Test is manufactured by the Roche Molecular Systems in Pleasanton, Calif.
 
Tarceva (erlotinib) is co-marketed by California-based Genentech, a member of the Roche Group and OSI Pharmaceuticals of Farmingdale, N.Y.
 
For more information:
 
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 

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