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Cetuximab as First-Line Treatment in Metastatic Colorectal Cancer Approved in Europe DARMSTADT, Germany -- July 23, 2008 -- The European Commission has approved for cetuximab (Erbitux) to update its license for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer (mCRC) in combination with chemotherapy and as a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapies and who are intolerant to irinotecan. "This broad approval of cetuximab in metastatic colorectal cancer is welcomed by the oncology community, as it provides us with another treatment option for our patients in the first-line setting," said Eric Van Cutsem, University Hospital Gasthuisberg, Leuven, Belgium. "We are excited by the data supporting this approval, as it demonstrates the increased efficacy of cetuximab in patients who have KRAS wild-type tumours. The broadened approval of cetuximab is also a big step towards offering tailored therapies to patients with metastatic colorectal cancer." The approval was granted following review of data from randomised, controlled, phase 3 and phase 2 trials that demonstrated the superior efficacy of cetuximab in combination with standard chemotherapy in the first-line treatment of patients with mCRC compared with chemotherapy alone. Further analyses of these trials found that patients experienced substantially increased efficacy with cetuximab and had statistically significant higher response rates and decreased risk of progression compared with patients receiving chemotherapy alone. SOURCE: Merck KGaA E-mail this page to a friend or colleague! To print, use this version