(The following is a reformatted version of a press release
issued by the FDA and received via electronic mail. The release
was confirmed by the sender.)
June 13, 2013
FDA approves Xgeva to treat giant cell tumor of the bone
The U.S. Food and Drug Administration today expanded the
approved use of Xgeva (denosumab) to treat adults and some
adolescents with giant cell tumor of the bone (GCTB), a rare and
usually non-cancerous tumor.
GCTB generally occurs in adults between the ages of 20 and 40
years. In most cases, GCTB does not spread to other parts of the
body but destroys normal bone as it grows, causing pain, limited
range of motion and bone fractures. Rarely,
GCTB can transform into a cancerous tumor and spread to the
Xgeva is a monoclonal antibody that binds to RANKL, a protein
essential for maintenance of healthy bone. RANKL is also present
in GCTB. Xgeva is intended for patients whose GCTB cannot be
surgically removed (unresectable) or when
surgery is likely to result in severe morbidity, such as loss of
limbs or joint removal. It should only be used in adolescents
whose bones have matured.
“Today’s approval of Xgeva provides a needed treatment option
for patients with GCTB who are not surgical candidates or who
would otherwise have to undergo extensive, life-altering
surgery,” said Richard Pazdur, M.D., director of the
Office of Hematology and Oncology Products in FDA’s Center for
Drug Evaluation and Research.
The FDA reviewed Xgeva under its priority review program, which
provides for an expedited review of drugs. Xgeva was granted
orphan product designation because it is intended to treat a
rare disease or condition.
The safety and effectiveness of Xgeva for GCTB were established
in two clinical trials that enrolled a total of 305 adult or
adolescent patients. All patients
had confirmed cases of GCTB that were recurrent, unresectable or
where surgery would result in severe morbidity.
Of the 187 patients whose tumors could be measured, 47 patients
had their tumors reduce in size after an average of three
months. Over an average follow-up duration of 20 months, re-growth of GCTB occurred in three patients whose
tumors originally became smaller during treatment.
Common side effects included joint pain (arthralgia), headache,
nausea, fatigue, back pain and extremity pain. The most common
serious side effects were osteonecrosis (areas of dead bone) of
the jaw and osteomyelitis (inflammation or infection of the
bone). Women of reproductive potential should
use highly effective contraception while taking Xgeva because of
potential fetal harm.
Xgeva was approved in 2010 to prevent fractures when cancer has
spread to the bones. It is marketed by Amgen, based in Thousand
For more information:
FDA: Office of Hematology and Oncology Products
FDA: Approved Drugs: Questions and Answers
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the
safety, effectiveness, and security of human and veterinary
drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation’s food supply, cosmetics,
dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.
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