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Amgen Receives Positive CHMP Opinion for Vectibix® (Panitumumab) in Combination With Chemotherapy
Date:6/24/2011

THOUSAND OAKS, Calif., June 24, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Vectibix® (panitumumab) be approved for use in the European Union (EU) 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) for patients with wild-type KRAS metastatic colorectal cancer (mCRC), following a successful re-examination procedure by Amgen.

"This opinion, for which a final European Commission decision is pending, is a welcome step forward and one that may lead to additional treatment options for patients facing an aggressive disease with limited treatment options," said Willard H. Dere, M.D., senior vice president and international chief medical officer at Amgen. "Studies have shown that patients taking Vectibix in combination with chemotherapy have a greater chance of living longer without their disease getting worse, in a landscape where few targeted agents have been shown to be effective when used with chemotherapy."

Data from studies 20050203 (PRIME) and 20050181 ('181) showed that adding Vectibix to either FOLFOX or FOLFIRI chemotherapy improved progression-free survival (PFS) versus chemotherapy alone for patients with wild-type KRAS mCRC. Additionally, the overall response rate (ORR) of Vectibix plus chemotherapy was higher than chemotherapy alone. Although numerically greater, the improvement in median overall survival (OS) did not achieve statistical significance in the Vectibix arm of either trial.(i)

The PRIME study evaluated Vectibix (6.0 mg/kg every two weeks) plus FOLFOX versus FOLFOX alone in patients with wild-type KRAS mCRC and found that V
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