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Amgen to Appeal CHMP Opinion on Vectibix® (Panitumumab) Use With Chemotherapy in Metastatic Colorectal Cancer in Europe
Date:3/30/2011

patients with wild-type KRAS mCRC, when standard chemotherapy is no longer effective. In the U.S., Vectibix received accelerated approval in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. Furthermore, use of Vectibix is not recommended in patients whose tumors have KRAS mutations in codon 12 or 13. In Japan and Israel, Vectibix is also approved for use in combination with chemotherapy for patients with wild-type KRAS mCRC.

About KRAS

Results 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 Cancer

Colorectal 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 Vectibix

Vectibix is the first fully human anti-EGFR antibody approved by the U.S. Food and Drug Administration (FDA) for the treatment of mCRC. Vectibix was approved in the U.S. in September 2006 as a monotherapy for the t
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