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Amgen Announces KRAS Safety Update to U.S. Prescribing Information for Vectibix(R) (Panitumumab)
Date:7/17/2009

THOUSAND OAKS, Calif., July 17 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today 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((R)) (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 medical officer and head of Global Development at Amgen.

The INDICATION AND USAGE section of the prescribing information has been updated to include that retrospective subset analyses of metastatic colorectal cancer trials have not shown a treatment benefit for Vectibix in patients whose tumors had KRAS mutations in codon 12 or 13. Use of Vectibix is not recommended for the treatment of colorectal cancer with these mutations.

The CLINICAL STUDIES section of the prescribing information has been updated to reflect results from retrospective analyses across seven randomized clinical trials with agents in this class. This includes the first Phase 3 analysis that showed mCRC patients with mutated KRAS tumors do not respond to monotherapy with an EGFr-inhibiting antibody (the Vectibix "408" trial).

"With this label update, physicians can now eliminate anti-EGFr antibodies as a treatment option for patients with mutated KRAS tumors and redirect those patients to alternative therapi
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SOURCE Amgen
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