Xgeva Approved for Rare, Non-Malignant Tumor06/13/13
THURSDAY, June 13 (HealthDay News) -- Xgeva (denosumab) has been
approved by the U.S. Food and Drug Administration to treat giant
cell tumor of the bone (GCTB), a rare tumor that's most often
The tumor usually affects adults between ages 20 and 40,
although it may also develop in adolescents, the FDA said Thursday
in a news release. It typically doesn't spread, although in rare
cases it can become cancerous and travel to the lungs.
As a non-cancerous tumor, GCTB destroys bone as it becomes
larger, causing pain, fractures and loss of mobility. Xgeva has
been approved in cases where the tumor can't be surgically removed,
or might lead to a severe outcome such as loss of a limb, the
Xgeva, approved under the FDA's expedited review program, was
evaluated for this use in two clinical trials involving a total of
305 adults and adolescents. Common side effects included joint
pain, headache, nausea, fatigue, back pain and extremity pain.
Women of childbearing potential should use "highly effective"
contraception while taking Xgeva, since the drug can harm a fetus,
the FDA warned.
The drug was first approved in 2010 to prevent fractures when
cancer has spread to the bone. It's marketed by Amgen, based in
Thousand Oaks, Calif.
The FDA has more about
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