ODAC to review KRAS biomarker
Executive Summary
FDA's Oncologic Drugs Advisory Committee will meet Dec. 16 to discuss the use of the KRAS mutation status as predictive/prognostic biomarker to evaluate patients more likely to respond to ImClone's Erbitux (cetuximab) and Amgen's Vectibix (panitumumab). The biomarker was highlighted at a plenary presentation of the CRYSTAL study at ASCO (1Pharmaceutical Approvals Monthly, June 1, 2008, p. 16). European labeling for the EGFR inhibitors already limits use to patients with the KRAS wild-type gene