FDA Expands Use of Cancer Rx

Xgeva approved to treat giant cell tumor of the bone

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Not all tumors are cancerous. For example, giant cell tumor of the bone (GCTB) is a rare disease that usually is not cancerous.

The US Food and Drug Administration (FDA) has approved Xgeva (denosumab) for the treatment of GCTB.

The medication is also approved to prevent fractures when cancer has spread (metastasized) to the bone.

"Ask your pharmacist about the latest medications for your condition."

GCTB generally develops in adults between the ages of 20 and 40. Adolescents can also get the disease.

GCTB destroys bone, which can be very painful. The condition can also limit range of motion and cause bone fractures.

In rare cases, GCTB can become cancerous and spread to the lungs.

Xgeva is approved for patients whose GCTB can’t be removed by surgery, or when an operation could result in loss of limbs or joints.

The medication can only be used in adolescents whose bones are fully grown.

The FDA approval is based on two clinical trials that involved 305 patients with GCTB. Each of the patients had GCTB that had returned (recurred) after previous treatment and could not be safely removed by surgery.

A total of 187 patients had tumors that could be measured. Of this group, Xgeva was effective in shrinking tumors in 47 individuals over a three-month period.

During the average 20 months of follow-up, GCTB started growing again in three patients whose tumors had shrunk during treatment.

Common side effects included joint pain, headache, fatigue, nausea, back pain and pain in extremities.

The most common serious side effects were osteonecrosis (areas of dead bone) of the jaw and osteomyelitis (inflammation or infection of the bone).

The review of this medication took place under the FDA’s priority review program, which is designed to expedite approvals of medications that can treat rare diseases or conditions.

A 1.7ml vial of Xgeva 120mg costs about $1,800.

Xgeva is marketed by Amgen.

Reviewed by: 
Review Date: 
June 13, 2013
Last Updated:
December 30, 2013