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Oncology
Oncology Biomarker KRAS to be Discussed at FDA Panel Meeting
December 30th, 2008
Amgen (NASDAQ: AMGN) 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...
Source: Cancer Weekly (2008-12-30)
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