Xgeva™ (denosumab) has been approved by the US Food and Drug Administration (FDA) for the prevention of bone complications such as fracture in patients with bone metastases from solid (not blood-related) cancers. It is not approved for patients with multiple myeloma or other cancers of the blood.
Metastatic cancer refers to cancer that has spread to distant sites in the body. Several types of cancer have a tendency to spread to the bone. Bone metastases can lead to serious problems such as fracture and spinal cord compression and may require treatment with surgery or radiation therapy.
Denosumab is a drug that targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). Denosumab was initially approved under the trade name Prolia® for the treatment of osteoporosis in postmenopausal women; it is now also approved under the trade name Xgeva for patients with bone metastases. Xgeva is administered using a higher dose and with more frequent dosing than Prolia.
The safety and efficacy of Xgeva were established in three clinical trials that compared Xgeva to the bisphosphonate drug Zometa® (zoledronic acid). One of the studies enrolled patients with breast cancer, one enrolled patients with prostate cancer, and the third enrolled patients with a variety of cancer types.
The studies assessed the frequency and timing of bone complications (“skeletal related events”). The bone complications that were evaluated were fracture, radiation to the bone, surgery to the bone, and spinal cord compression. In the studies of breast and prostate cancer patients, Xgeva delayed bone complications to a greater extent than Zometa. In the study of patients with other cancer types, Xgeva and Zometa produced similar results.
The approval of Xgeva expands the treatment options available to patients with bone metastases.
Reference: US Food and Drug Administration news release. FDA approves Xgeva to help prevent cancer-related bone injury. November 19, 2010.