Briefing documents for the December 16th Oncologic Drugs Advisory Committee (ODAC) meeting convened to review the level of evidence from KRAS as a predictive biomarker in the context of Vectibix® (panitumumab) and other epidermal growth factor receptor (EGFr) monoclonal antibody therapies in advanced colorectal cancer are now available at www.fda.gov.

“Amgen believes that the benefit:risk profile of Vectibix will be improved by restricting monotherapy use to those patients whose tumors have the wild-type KRAS gene. This would not only limit use to patients likely to have improved clinical outcome with Vectibix, but would also prevent unnecessary exposure and potential toxicity in those unlikely to benefit. Discussions with FDA on the utility of these data to effect a change to the current Vectibix monotherapy label are ongoing.

Two large ongoing Phase 3 studies examining Vectibix with chemotherapy in first and second-line metastatic colorectal cancer will provide more definitive data regarding the clinical utility of KRAS as a predictive biomarker in the combination therapy setting. These trials have completed enrollment and will have data available in 2009.

Amgen looks forward to a robust discussion with the Advisory Committee on the role of KRAS as a predictive and/or prognostic biomarker.”