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FDA Approves Xgeva for Rare Bone Disorder

On Thursday, the FDA expanded its approval of Xgeva (denosumab) for treatment in adults and select adolescents with giant cell tumor of the bone (GCTB)–a rare condition that causes non-cancerous tumors.

The condition usually occurs in adults, aged 20-40 and in most cases, the tumors don’t spread to other parts of the body. It does, however, destroy normal bone as it grows. This can cause fractures, limited ranged of motion, and pain. In rare instances, GCTB can become a cancerous tumor and spread to the lungs.

Xgeva is indicated for patients with inoperable GCTB or when surgery may result in the loss of limbs or the removal of a joint.

Richard Pazdur, M.D. director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, 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.”

The drug was originally approved in 2010 to prevent fractures when cancer had spread to the bones.

Xgeva is marketed by biotech firm, Amgen (NASDAQ: AMGN). The stock is up nearly one percent on the news.

Disclosure: At the time of this writing, Cassandra Moore had no position in the equities mentioned.

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