Xgeva Approved to Prevent Fractures in Bone Cancer Patients
Blocks protein that destroys bone cells
FRIDAY, Nov. 19, 2010 (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 (spread) to the bones.
As many as 75 percent of people with advanced cancer of the prostate, lung or breast have it spread to the bones, Xgeva's manufacturer, Amgen Inc., said in a news release. This may lead to complications such as debilitating pain, bone fractures and compression of the spinal cord, the drug maker said.
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 was superior to, or at least as effective, 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.
To learn more about this approval, visit the FDA.