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Amgen Announces KRAS Safety Update to U.S. Prescribing Information for Vectibix(R) (Panitumumab)
Date:7/17/2009

es, avoiding unnecessary treatments in patients who are unlikely to benefit," said Sean Harper.

This label update is specific to the utility of KRAS as a biomarker for Vectibix used as a monotherapy. In the combination chemotherapy setting, the Vectibix "181" and "PRIME (203)" trials will be the first prospective Phase 3 clinical studies testing the clinical utility of KRAS as a predictive biomarker in mCRC patients in earlier lines of therapy. Data from the "181" and "PRIME (203)" trials are expected in the third quarter of 2009.

This update follows recent KRAS related action from key cancer organizations, including the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN). A Clinical Provisional Opinion (CPO) was issued by ASCO in January, where the organization recommended the use of the KRAS biomarker in selecting the appropriate patients for anti-EGFr antibody therapy. In November 2008, the NCCN announced updates to their Guidelines on Colon and Rectal Cancers. The guideline updates included the recommendation that a determination of the KRAS gene status of either the primary tumor or a site of metastasis should be part of the pre-treatment work-up for patients diagnosed with metastatic colorectal cancer.

About Colorectal Cancer

Colorectal cancer is the third most common cancer diagnosed in men and in women in the United States (U.S.). The American Cancer Society estimates that about 106,100 new cases of colon cancer and 40,870 new cases of rectal cancer will be diagnosed in 2009. Colorectal cancer is the second leading cause of cancer death among men and women in the U.S. and it has been estimated that more than 49,000 people will die from colorectal cancer in 2009. That means that one person in the U.S. dies of colorectal cancer every 9.3 minutes.

About Vectibix


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