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Amgen Presents New XGEVA™ (Denosumab) Breast Cancer Skeletal-Related Event Prevention Data at SABCS
Date:12/10/2010

THOUSAND OAKS, Calif., Dec. 10, 2010 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced results from new analyses comparing XGEVA™ (denosumab), the first new treatment for advanced cancer patients with bone metastases in nearly a decade to prevent skeletal-related events, to Zometa® (zoledronic acid). These results underscore the efficacy profile of XGEVA in preventing skeletal-related events (SREs) in patients with bone metastases from advanced breast cancer, as well as explore XGEVA's impact on pain and quality of life outcomes, compared to Zometa. These new results were presented at the 33rd Annual San Antonio Breast Cancer Symposium.

XGEVA was approved on Nov. 18, 2010 by the U.S. Food and Drug Administration (FDA) after a priority review, a designation reserved for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. XGEVA is indicated for the prevention of SREs in patients with bone metastases from solid tumors. XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma.

New Extended Treatment Phase Data from Pivotal Phase 3 Study "136" Demonstrates Continued Superiority of XGEVA Compared to Zometa (Abstract Number: P6-14-01)San Antonio Sponsored Press Briefing, Dec. 10, 2010 at 12:30 p.m. CT

An additional four months of double-blinded treatment data from the pivotal Phase 3 "136" study was presented in a press briefing at SABCS today. The data showed that XGEVA was superior to Zometa in delaying the time to first on-study SRE by 18 percent and time to first-and-subsequent on-study event by 22 percent.  Further, the median time to first on-study SRE was five months longer for the patients at risk in the XGEVA group (32.4 months) versus the Zometa group (27.4 months) in patients with advanced breast cancer and bone metastases HR 0.82 (95 percent C
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SOURCE Amgen
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