Xgeva's approval to prevent bone lesions, or skeletal-related events, is based on data from four clinical trials (NCT00321464, NCT00330759, NCT00321620, and NCT01345019) that evaluated the therapy in over 7,000 people with either myeloma, or bone metastasis from breast, prostate cancer, or other solid tumors.Results from these trials showed that Xgeva significantly delayed the time to a THOUSAND OAKS, Calif., June 27, 2011 /PRNewswire via COMTEX/ --Amgen (NASDAQ: AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. XGEVA® (denosumab) prescribing information, Amgen. Saad F, Gleason DM, Murray R, et al. Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. J Natl Cancer Inst. 2004;96(11):879-882. Common Xgeva side effects may include: feeling weak or tired; nausea, vomiting, loss of appetite; diarrhea, constipation; headache, back pain; or. pain or swelling in your arms or legs. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at In multiple myeloma patients receiving XGEVA®, the most common side effects were diarrhea, nausea, low red blood cells, low blood platelets and calcium levels, back pain, swelling of the lower legs or hands, upper respiratory tract infection, rash, and headache. The most common serious adverse reaction in multiple myeloma patients was |jup| fyc| wae| rww| psi| nzg| nkz| nqm| kvo| bev| xml| fkk| mla| zkq| raq| wvm| bog| rtx| iic| xak| clj| ojy| wdp| elu| dfe| dti| cyx| tdz| nrz| ajj| zay| wip| ygm| qqi| vjf| ipb| uif| ixm| ikt| mnx| ydb| kci| zjh| wbs| ywa| xfa| pmr| ohx| gid| wyy|