Xgeva Approved for Giant Cell Tumor of the Bone

The FDA has expanded the use of Xgeva (denosumab; Amgen) to treat adults and adolescents with unresectable giant cell tumor of the bone (GCTB) or when surgery is likely to result in severe morbidity (eg, loss of limbs or joint removal). Xgeva is an osteoclast inhibitor (RANKL inhibitor) that works by binding to RANKL, a protein essential for maintenance of healthy bone.

The FDA reviewed Xgeva under its priority review program and it was later granted orphan product designation. The safety and effectiveness for Xgeva in GCTB were established in two trials that enrolled a total of 305 adult or adolescent patients.

Out of the total 187 patients whose tumors could be measured, 47 patients had their tumors reduce in size after an average of three months. Over an average follow-up of 20 months, re-growth of GCTB occurred in three patients whose tumors originally became smaller during treatment.

Xgeva is already approved for the prevention of skeletal-related events (SRE) in patients with bone metastases from solid tumors. It is not approved for preventing SRE with multiple myeloma.

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