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Qiagen wins U.S. approval for test to accompany Amgen cancer drug

Started by riky, May 25, 2014, 09:00:20 AM

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riky

Qiagen wins U.S. approval for test to accompany Amgen cancer drug

U.S. health regulators on Friday approved Qiagen NV's gene-testing kit to identify those colorectal cancer patients most likely to benefit from Amgen Inc's drug, Vectibix, Qiagen said. In addition, the Food and Drug Administration expanded the approval of Vectibix to allow its use as a first-line, or initial, treatment for colon cancer in combination with the widely used FOLFOX chemotherapy regimen, Amgen said. The expanded Vectibix approval is for patients who have a non-mutated, or wild type, KRAS gene after clinical trials demonstrated that those patients were most likely to be helped by the drug.

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