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FDA to Review Potential New Use of XGEVA® (Denosumab) at Oncologic Drugs Advisory Committee Meeting
Date:12/29/2011

n patients with bone metastases from solid tumors.  XGEVA is not approved to prevent SREs in patients with multiple myeloma.

Amgen has also submitted marketing applications for XGEVA in Mexico, South Africa, Gulf Cooperation Council countries, Morocco, and Egypt. In Japan, Amgen is working with its licensing partner, Daiichi Sankyo Company, Limited and a marketing application was submitted. 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.

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. [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.

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