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Amgen Submits Application to Expand Indication for XGEVA® (Denosumab) to Prevent or Delay Spread of Prostate Cancer to the Bone
Date:6/27/2011

six month priority review by the FDA. In the U.S., XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma.(iv)  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, Switzerland and the European Union. 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.

For more information on XGEVA, please visit www.XGEVA.com.

Denosumab is also marketed as Prolia® in other indications.

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 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
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