WASHINGTON (AP) -- The Food and Drug Administration on Friday approved a genetic test to help doctors more quickly determine which late-stage colon cancer patients will respond to the drug Erbitux, and which won't benefit from the treatment.
The test, developed by Qiagen NV, detects the so-called KRAS gene mutation. Patients with the mutation generally don't respond to Erbitux, but patients without KRAS have been shown to live more than three months longer on Erbitux than those who did not receive the drug. Having this information allows doctors and patients to start Erbitux right away or move forward with alternate treatments.
Erbitux, co-marketed by Bristol-Myers Squibb and Eli Lilly & Co., is a biotech drug approved to treat colon cancer patients for whom chemotherapy has failed to prevent the disease from spreading. In 2009, the FDA added labeling to the drug stating that it does not work in patients with the KRAS gene.
Clinical laboratories already perform tests for the KRAS mutation. In a statement, Qiagen said that its test can generate results in under 5 hours, compared with 9 to 11 hours for most laboratory-run tests. The company's test also is the first officially approved by the FDA for use in screening patients considering treatment with Erbitux.
Colon cancer is the third leading cause of death in the U.S., claiming 50,000 lives each year, according to the American Cancer Society.
Qiagen, based in the Netherlands, estimates the potential U.S. market for the test is about $20 million. U.S.-listed shares closed Friday down 35 cents, or 2 percent, at $16.70.