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Results Published in The Lancet Demonstrate Superiority of XGEVA™ (Denosumab) in the Prevention of Bone Complications for Men With Bone Metastases From Advanced Prostate Cancer
Date:2/24/2011

THOUSAND OAKS, Calif., Feb. 24, 2011 /PRNewswire/ -- Amgen (Nasdaq: AMGN) today announced the publication of results from a Phase 3 head-to-head trial that compared XGEVA (denosumab) to Zometa® (zoledronic acid) in preventing bone complications called skeletal-related events (SREs) in 1,901 men with prostate cancer and bone metastases. The study, published in The Lancet, met its primary and secondary endpoints and demonstrated XGEVA's superiority compared to Zometa in preventing SREs.

XGEVA was approved by the U.S. Food and Drug Administration (FDA) on Nov. 18, 2010 for the prevention of SREs in patients with bone metastases from solid tumors, including prostate cancer.  XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma.  XGEVA, the first and only FDA-approved RANK Ligand inhibitor, is the first new treatment for advanced cancer patients with bone metastases in nearly a decade.  

"Bone metastases represent a significant risk for advanced prostate cancer patients due to the potential for serious bone complications such as fracture and spinal cord compression," said Karim Fizazi, M.D., Ph.D., head of the department of Medical Oncology, Institut Gustave-Roussy, Villejuif, France. "The results of this study show that XGEVA prevents these serious bone complications more effectively than Zometa without the requirement of intravenous infusion and without the need for dose adjustment for renal function.  XGEVA represents an important new treatment option for advanced prostate cancer patients with bone metastases."

Bone metastases, the spread of cancer to the bones, are a serious concern for patients with advanced cancer and present a considerable burden to the healthcare system. Weakened bones due to metastases can lead to fractures and compression of the spinal cord and necessi
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SOURCE Amgen
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