FDA approves Amgen's Xgeva for giant cell tumor of the bone

SILVER SPRING, Md. – The Food and Drug Administration has approved a drug made by Amgen for treating a rare and usually noncancerous bone tumor, the agency said Thursday.

The FDA announced the approval of Xgeva (denosumab) for adults and some adolescents with giant cell tumor of the bone, also known as GCTB. In most cases, GCTB, which usually occurs in adults age 20 years to 40 years, does not spread to other parts of the body, but destroys bone tissue as it grows, causing pain, limited range of motion and fractures. In some rare cases, it can turn into a cancerous tumor and spread to the lungs, the FDA said.

"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," FDA Office of Hematology and Oncology Products director Richard Pazdur said.