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Oncology Biomarker KRAS to be Discussed at FDA Panel Meeting
Date:12/16/2008

KRAS Biomarker PresentsPotential toPersonalize Colorectal Cancer Treatment Determining Who Can Benefit from Vectibix(R)

THOUSAND OAKS, Calif., Dec. 16 /PRNewswire-FirstCall/ --Amgen (Nasdaq: AMGN) today announced they will discuss the clinical utility of the KRAS gene as a predictive biomarker in patients with metastatic colorectal cancer (mCRC) treated with anti-epidermal growth factor receptor (EGFr) antibody Vectibix(R) (panitumumab) with the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC).

We believe that data shared with the Committee support the suggestion that KRAS is a predictive biomarker for the anti-EGFr class of drugs in the monotherapy setting. In March 2008, the Journal of Clinical Oncology published results from an analysis of the first randomized, controlled clinical trial ("408") which showed that mCRC patients with mutated KRAS tumors do not respond to Vectibix monotherapy. Conversely, patients with wild-type KRAS tumors treated with Vectibix have a better response rate and prolonged progression-free survival (PFS).

"These data are consistent with 30 years of biology which indicate that KRAS is a clinically relevant oncogene," said Sean Harper, M.D., chief medical officer and head of Global Development at Amgen. "We believe the data from our "408" monotherapy trial that will be presented today indicate that the benefit-risk profile of Vectibix is improved by restricting use to those patients with mCRC whose tumors have wild-type KRAS genes."

To further independently evaluate the association of KRAS status seen in the "408" trial, additional retrospective analyses of all other studies of Vectibix monotherapy in mCRC were performed. A pooled analysis, presented at the European
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SOURCE Amgen
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