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Amgen Highlights Data to be Presented at 2011 European Multidisciplinary Cancer Congress
Date:9/23/2011

clinical trials, XGEVA demonstrated a clinically meaningful improvement compared to the standard of care in preventing bone complications. XGEVA is also being investigated for the potential use to delay the onset of bone metastasis in adjuvant breast cancer.

XGEVA Important Safety InformationXGEVA can cause severe hypocalcemia. Correct pre-existing hypocalcemia prior to XGEVA treatment. Monitor calcium levels in patients at greater risk of developing hypocalcemia. Administer calcium and vitamin D in all patients (unless hypercalcemia is present). Advise patients to contact a healthcare professional for symptoms of hypocalcemia.

Osteocronosis of the jaw (ONJ) can occur in patients receiving XGEVA. Patients who are 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.

Adverse reactions in patients receiving XGEVA included fatigue/asthenia, hypophosphatemia, nausea, dyspnea and diarrhea.

Please visit http://www.amgen.com for full U.S. prescribing information.

XGEVA Skeletal-Related Events Regulatory StatusThe European Commission (EC) granted a Marketing Authorization for XGEVA for the prevention of SREs (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors. As part of the review, the EC also granted XGEVA  one additional year of marketing protection based on the indication being considered new for denosumab and the significant clinical benefit offered by the product in comparison with existing therapies.

XGEVA is also approved in Canada for reducing the risk of developing SREs in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumors.  In Canada, XGEVA is not indicated for reduc
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