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Amgen Receives Positive CHMP Opinion for Vectibix® (Panitumumab) in Combination With Chemotherapy
Date:6/24/2011

The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA, EMA or similar regulatory bodies can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the approved labeling for the products, and not the information discussed in this news release.

CONTACT: Amgen
Carrie Deverell: +41 41 3690 308 (E.U. media)
Christine Regan: +1 805-447-5476 (U.S. media)
Arvind Sood: +1 805-447-1060 (investors)

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(i)  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.

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

(iii)  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.

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

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

(vi)  Friday BB and Adjei AA. K-ras as
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