FDA Approves Xgeva to Treat Giant Cell Tumor of the Bone

The Food and Drug Administration June 13 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 noncancerous tumor.

Xgeva, which is manufactured by Thousand Oaks, Calif.-based Amgen Inc., was approved in 2010 to prevent fractures when cancer has spread to the bones (8 PLIR 1524, 12/3/10).

The drug 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, the agency said. Xgeva should ...