Xgeva Approved to Prevent Fractures in Bone Cancer Patients

Blocks protein that destroys bone cells

FRIDAY, Nov. 19 (HealthDay News) -- Xgeva (denosumab) has been approved by the U.S. Food and Drug Administration to prevent fractures and other skeletal complications in people with advanced cancer that has metastasized to the bones.

Xgeva, injected once monthly, targets a cancer-related protein that destroys bone cells, the FDA said in a news release. The drug's safety and effectiveness were evaluated in clinical studies involving 5,723 people. The trials showed Xgeva worked about as well as an older drug designed to reduce bone complications from cancer, Zometa (zoledronic acid).

Side effects of Xgeva included lower blood calcium levels, and osteonecrosis of the jaw, a severe disease resulting from reduced blood flow to the jaw, the FDA said.

In June, the drug was first approved under a different name, Prolia, to treat postmenopausal women at high risk of osteoporotic bone fractures.

Amgen is based in Thousand Oaks, Calif.

More information

To learn more about this approval, visit the FDA.

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