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 resulting in discontinuation of XGEVA were osteonecrosis and hypocalcemia.  Please visit www.amgen for full prescribing information.

Denosumab is also marketed as Prolia?® in other indications.

XGEVA Skeletal-Related Events Regulatory Status

XGEVA was approved by the FDA for the prevention of SREs in patients with bone metastases from solid tumors on Nov. 18, 2010. XGEVA is not indicated to prevent SREs in patients with multiple myeloma.

Administered as a single 120 mg subcutaneous injection every four weeks, XGEVA provides a new option for urologists and oncologists to prevent serious bone complications in men with prostate cancer.

Amgen has also submitted marketing applications for XGEVA in the European Union, Australia, Canada and Switzerland. In Japan, Amgen is working with its licensing partner, Daiichi-Sankyo Company, Limited and a marketing application was submitted.

Bone Metastases and Skeletal Related Events: 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 75 percent of patients with metastatic disease.(i)

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

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 this newly approved indication, XGEVA is also being investigated for its potential to delay bone metastases in prostate and breast cancer.

SOURCE Amgen