Colon Cancer
Amgen Announces KRAS Safety Update to U.S. Prescribing Information for Vectibix(R) (Panitumumab)
Published in Cancer Weekly, August 4th, 2009
Amgen Inc. (NASDAQ:AMGN) announced the U.S. Food and Drug Administration (FDA) has approved revisions to the U.S. prescribing information for the epidermal growth factor receptor (EGFr) class of antibodies, including Vectibix (panitumumab). This decision follows the FDA's December 2008 Oncologics Drugs Advisory Committee (ODAC) meeting where the clinical utility of the KRAS gene as a predictive biomarker in patients with metastatic colorectal cancer (mCRC) treated with anti-EGFr antibody was discussed.
"We are pleased that the FDA has recognized the clinical importance of KRAS as a predictive biomarker for anti-EGFr antibody therapy," said Sean Harper, M.D., chief...
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Source: Cancer Weekly (2009-08-04)
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