Amgen 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 KRASmCRC. 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 (therascreenKRAS test)  as a companion diagnostic for Vectibix.

For more details, go to: http://www.amgen.com/media/media_pr_detail.jsp?releaseID=1934128