FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer

SILVER SPRING, Md., June 1, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 percent of non-small cell lung cancers (NSCLC).

Lung cancer is the leading cause of cancer-related death among men and women in the U.S. and, though more common in men, the number of deaths from lung cancer in women is increasing. According to the National Cancer Institute, an estimated 221,200 Americans will be diagnosed with lung cancer, and 158,040 will die from the disease this year. NSCLC is the most common type of lung cancer. NSCLC tumors may shed tumor DNA into a patient's blood, making it possible to detect specific mutations in blood samples. Testing for tumor DNA using a blood sample is also called a "liquid biopsy."

"Approvals of liquid biopsy tests make it possible to deliver highly individualized health care for patients," 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. "Liquid biopsies also have the potential to allow physicians to identify patients whose tumors have specific mutations in the least invasive way possible."

With the cobas EGFR Mutation Test v2, the presence of specific NSCLC mutations [exon 19 deletion or exon 21 (L858R) substitution mutations] detected in patients' blood samples aids in selecting those who may benefit from treatment with Tarceva. However, if such mutations are not detected in the blood, then a tumor biopsy should be performed to determine if the NSCLC mutations are present. Insofar as the test provides positive results, it may benefit patients who may be too ill or are otherwise unable to provide a tumor specimen for EGFR testing.

The efficacy of the cobas EGFR Mutation Test v2 using blood samples was determined by using the test to identify the EGFR mutation status in patients enrolled into a clinical trial whose tumor biopsies were previously confirmed positive for the EGFR exon 19 deletion or L858R mutations as determined by the cobas EGFR Mutation Test v1.

The FDA approved Tarceva in 2004 to treat patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen, and in 2013, the FDA approved it for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors having EGFR exon 19 deletions or L858R substitution mutations as detected by an FDA-approved test. The most common side effects of Tarceva are rash, diarrhea, anorexia, fatigue, difficulty breathing (dyspnea), cough, nausea and vomiting. Tarceva is not recommended for use in combination with platinum-based chemotherapy and the drug has not been evaluated as first-line treatment in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or L858R substitution mutations.

The cobas EGFR Mutation Test v2 is manufactured by Roche Molecular Systems in Pleasanton, California. Tarceva is manufactured by Astellas Pharma Technologies, Inc. of Norman, Oklahoma and distributed by Genentech Inc., of South San Francisco, California.

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 is also responsible for the safety and security of our nation's food supply, cosmetics, and dietary supplements, for products that give off electronic radiation, and for regulating tobacco products.

For more information:

• FDA: Medical Devices
• FDA: CDRH Office of In Vitro Diagnostic Device Evaluation and Safety
• FDA Approved Drugs: Questions and Answers

Media Inquiries: Angela Stark, [email protected], 301-796-0397
Consumer Inquiries: 888-INFO-FDA

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SOURCE U.S. Food and Drug Administration

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