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

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Overall rates of adverse events and serious adverse events were generally similar between XGEVA and Zometa. Osteonecrosis of the jaw (ONJ) was infrequent, with no statistically significant difference between treatment arms. Hypocalcemia was more frequent in the XGEVA treatment group. Overall survival and progression-free survival were similar between arms in all three trials.

XGEVA Regulatory Status

XGEVA is currently approved in the United States (U.S.) for the prevention of SREs in patients with bone metastases from solid tumors.  XGEVA was approved following a six month priority review by the U.S. Food and Drug Administration (FDA). In the U.S., XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma.(i)   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 reducing the risk of developing SREs in patients with multiple myeloma.

Amgen has also submitted marketing applications for XGEVA in Australia, Mexico, Russia and Switzerland. In Japan, Amgen is working with its licensing partner, Daiichi Sankyo Company, Limited and a marketing application was submitted in August. In addition, Amgen and GlaxoSmithKline (GSK) have a collaboration agreement for the commercialization of XGEVA in a number of countries where Amgen does not currently have a commercial presence. In these countries, marketing applications are filed by GSK.

XGEVA Important Safety Information

XGEVA can cause severe hypocalcemia. Correct pre-existing hypocalcemia prior to XGEVA treatment. Monitor calcium levels and administer calcium, magnesium, and vitamin D as necessary. Advise patients to contact a healthcare professional for symptoms of hypocalcemia.

ONJ can occur in patients receiving XGEVA. Patients who are
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SOURCE Amgen
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