FDA backs Amgen's Xgeva for new use, to treat giant cell tumor of the bone

The US Food and Drug Administration late yesterday (June 13) expanded the approved use of biotech major Amgen’s (Nasdaq: AMGN) Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.

Xgeva was approved in 2010 to prevent fractures when cancer has spread to the bones, and in the first quarter of this year generated global sales of $365 million, a year-n-year rise of 46% (The Pharma Letter April 24). The new indication makes the drug the first and only treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, commented Amgen.

The FDA noted that 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 lungs.