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

p>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.(2)(3) The Amgen PRIME and '181 studies were among the first Phase 3 studies to prospectively analyze the effect of an anti-epidermal growth factor receptor (EGFR) inhibitor based on KRAS status in patients with mCRC.

Adverse events in the PRIME and '181 studies included known toxicities associated with EGFR therapy, such as rash, diarrhea, and hypomagnesemia. The incidence of grade 3/4 infusion reactions in the treatment arms for the two trials was approximately one percent.  In patients with mutated KRAS tumors, outcomes were inferior for those receiving Vectibix plus FOLFOX versus FOLFOX alone. Vectibix should only be used in those patients in whom wild-type KRAS status has been confirmed.

"Today's decision by the EC to extend the therapeutic indications for Vectibix marks a promising step forward for those patients facing an aggressive disease where limited treatment options are available," said Willard H. Dere, M.D., senior vice president and international chief medical officer at Amgen. "This is a significant milestone for Amgen and highlights our commitment to deliver medicines that make a real difference to the lives of patients."

Vectibix is already approved and established in more than 40 countries as a monotherapy treatment for patients with wild-type KRAS mCRC, when standard chemotherapy is no longer effective. In the United States (U.S.), Vectibix received accelerated approval in September 2006 as a mon
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SOURCE Amgen Europe GmbH
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