THOUSAND OAKS, Calif., May 23, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Vectibix ® (panitumumab) for use in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, as first-line treatment in patients with wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC). With this approval, Vectibix becomes the first and only biologic to offer a significant survival benefit as a first-line treatment with FOLFOX, one of the most commonly used chemotherapy regimens in the first-line setting for patients with wild-type KRAS mCRC. In addition, this approval converts the accelerated monotherapy approval to a full approval for Vectibix. FDA also approved the therascreen ® KRAS RGQ PCR Kit developed by QIAGEN ( therascreen KRAS test) as a companion diagnostic for Vectibix.
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Today's announcement is the latest milestone in Amgen's pioneering cancer biomarker research, aimed at helping oncologists personalize cancer treatment to improve patient outcomes. Biomarkers are biological characteristics that demonstrate the likelihood of an individual's response or lack of response to a particular therapy and are a key element in personalized medicine that can help oncologists choose treatments for patients who are most likely to benefit.