Amgen's Xgeva receives FDA approval

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for preventing skeletal injuries in patients whose cancer has spread to the bone.


The FDA announced Friday the approval of Thousand Oaks, Calif.-based biotech company Amgen’s Xgeva (denosumab) for bone metastases.



The drug is a monoclonal antibody that targets RANKL, a protein involved in the destruction of bones in patients with cancer. Other treatments for similar conditions include Novartis’ drugs Zometa (zoledronic acid) and Aredia (pamidronate disodium).



“Bone metastases represent a major cause of pain and suffering in patients with cancer and can affect a patient’s quality of life,” FDA Office of Oncology Drug Products director Richard Pazdur said. “Xgeva has a different mechanism of action than currently approved drugs aimed at reducing bone complications from cancer.”


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