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Amgen Announces PDUFA Date for XGEVA® Supplemental Biologics License Application
Date:8/22/2011

million patients with cancer worldwide and are most commonly associated with cancers of the prostate, lung, and breast, with incidence rates as high as 90 percent of patients with metastatic disease. (i) (ii) (iii) (iv)

Approximately 50-70 percent of cancer patients with bone metastases will experience debilitating SREs.(v) (vi) (vii)   Events considered to be SREs include fractures, spinal cord compression, and severe bone pain that may require surgery or radiation. (viii)  Such events can profoundly disrupt a patient's life and can cause disability and pain. (ix) (x) (xi)

Denosumab and Amgen's Research in Bone Biology

The denosumab development program demonstrates Amgen's commitment to researching and delivering pioneering medicines to patients with unmet medical needs. Amgen is studying denosumab in numerous tumor types across the spectrum of cancer-related bone diseases. Over 11,000 patients have been enrolled in the denosumab oncology clinical trials. In addition to the prevention of SREs, XGEVA is also being evaluated for its potential to delay bone metastases in adjuvant breast cancer.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics.  A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient.  Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses.  With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.  To learn more about our pioneering science and our vital medicines, visit www.amgen.com.

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