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Amgen Statement on CHMP Opinion on Vectibix® (Panitumumab) Use With Chemotherapy in Metastatic Colorectal Cancer
Date:3/18/2011

mbination have a greater chance of living longer without their disease getting worse.  Additionally, the response rate 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)(ii)

In general, adverse events rates were comparable across arms in both studies, with the exception of known toxicities associated with anti-EGFR therapy, such as rash, diarrhea, and hypomagnesemia. Vectibix-related grade 3/4 infusion reactions were reported in less than one percent of patients. In patients with mutated KRAS tumors, outcomes were inferior for those receiving Vectibix plus FOLFOX versus FOLFOX alone. (iii)(iv)

About KRASResults from studies performed over the last 25 years indicate that KRAS plays an important role in cell growth regulation. In mCRC, EGFR transmits signals through a set of intracellular proteins. Upon reaching the nucleus, these signals instruct the cancer cell to reproduce and metastasize, leading to cancer progression.(v) Anti-EGFR antibody therapies work by inhibiting the activation of EGFR, thereby inhibiting downstream events that lead to malignant signaling. However, in patients whose tumors harbor a mutated KRAS gene, the KRAS protein is always turned "on," regardless of whether the EGFR has been activated or therapeutically inhibited. KRAS mutations occur in approximately 40-50 percent of mCRC patients.(vi)(vii)

About Colorectal CancerColorectal cancer is the third most common cancer worldwide in men and the second most common in women. In 2008, approximately 1.23 million cases of colorectal cancer were diagnosed globally.(viii) In 2008, there were an estimated 333,330 new cases of colorectal cancer in the EU.(ix)

About VectibixVectibix is the first fully human anti-EGFR antibody approved by
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