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Xgeva Approved to Prevent Fractures in Bone Cancer Patients

Xgeva Approved to Prevent Fractures in Bone Cancer Patients

11/19/10

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 (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.

More information

To learn more about this approval, visit the FDA.

Copyright © 2010 HealthDay. All rights reserved.

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.

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