-- Scott Roberts
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
Amgen is based in Thousand Oaks, Calif.
To learn more about
this approval, visit the FDA.
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