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Vectibix® (Panitumumab) Granted Approval for Expanded Indications in the European Union
Date:11/15/2011

THOUSAND OAKS, Calif., Nov. 15, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the European Commission (EC) has approved a variation to the marketing authorization for Vectibix® (panitumumab) to include indications for the treatment of patients with wild-type KRAS metastatic colorectal cancer (mCRC) in first-line in combination with FOLFOX and in second-line in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). This approval of Vectibix applies to all 27 European Union (EU) member states. Prior to this approval, Vectibix had received conditional approval in the EU as monotherapy. The monotherapy indication was also further revised to state that Vectibix is indicated for the treatment of patients with wild-type KRAS mCRC as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Colorectal cancer is the second most common cancer in women worldwide and the third most common cancer in men. Approximately 1.2 million cases of colorectal cancer are expected to occur globally. With more than 630,000 deaths worldwide per year, it is the third leading cause of cancer-related death in the Western world. The highest incidence rates are found in Japan, North America, parts of Europe, New Zealand, and Australia, and rates are low in Africa and Southeast Asia.(1)

"Colorectal cancer can have a devastating impact on the lives of patients affected by this disease," said Professor Jean-Yves Douillard, director of Clinical and Translational Research, ICO Centre R Gauducheau, France. "This European Commission approval for Vectibix earlier in the treatment continuum marks a welcome and important addition of treatment choice in an area where few targeted agents have shown to be effective when used with chemotherapy."

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