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

orectal Cancer. J Clin Oncol 28. 2010.

(ii) Peeters, M et al. Randomized Phase III Study of Panitumumab With Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) Compared With FOLFIRI Alone As Second-Line Treatment in Patients With Metastatic Colorectal Cancer. J Clin Oncol 28, 2010.

(iii) Adverse event rates were comparable across arms with the exception of known toxicities associated with anti-epidermal growth factor receptor (EGFR) therapy such as rash, diarrhea and hypomagnesemia. Vectibix-related grade 3 infusion reactions were reported for two patients (less than 1 percent).

(iv) In general, adverse events rates were comparable across arms with the exception of known toxicities associated with anti-epidermal growth factor receptor (EGFR) therapy such as rash, diarrhea, and hypomagnesemia. Vectibix-related grade 3/4 infusion reactions were reported in less than one percent of patients.

(v) Malumbres, M. and Barbacid, M. RAS oncogenes: the first 30 years. Nature Reviews Cancer. 3:459-65, 2003.

(vi) Karapentis C, S. Snell, L, E. The Laboratory Assessment of KRAS Mutation Status in Colorectal Cancer. Asia, Pacific Journal of Oncology and Hematology. 2010.

(vii) Friday BB and Adjei AA. K-ras as a target for cancer therapy. Biochim. Biophys. Acta 1756: 127-144, 2005.

(viii) Ferlay J, Shin HR, Bray F, Forman D, Mathers C and Parkin DM. GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10. Lyon, France: International Agency for Research on Cancer; 2010.

(ix) Ferlay J, Parkin  DM, Steliarova-Foucher E Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer. 2010 Mar; 46(4):765-81. Epub 2010 Jan 29.'/>"/>

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