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Amgen Receives CHMP Positive Opinion for XGEVA™ (Denosumab) in the European Union
Date:5/20/2011

suspected of having or who develop ONJ while on XGEVA should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.

The most common adverse reactions in patients receiving XGEVA were fatigue/asthenia, hypophosphatemia, and nausea. The most common serious adverse reaction in patients receiving XGEVA was dyspnea. The most common adverse reactions resulting in discontinuation of XGEVA were osteonecrosis and hypocalcemia. Please visit http://www.amgen.com for full U.S. prescribing information.

Bone Metastases and SREs: Prevalence and Impact

Bone metastases occur in more than 1.5 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. (ii) (iii) (iv) (v)

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

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 prostate and breast cancer.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biot
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