Xgeva Approved for Preventing Cancer Related Bone Complications

Kathleen Blanchard's picture

The FDA has approved the drug Xgeva (denosumab) for treatment of bone fractures and pain that occurs with cancer spread. The drug is designed to improved quality of life for cancer patients and is a monoclonal antibody that worked better than Zometa for breast cancer patients.

Safety of Xgeva Confirmed in Three Studies

According to Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, “Xgeva has a different mechanism of action than currently approved drugs aimed at reducing bone complications from cancer. Its safety was confirmed in three separate trials that included patients with breast, prostate and a variety of other cancers.


For men with prostate cancer, Xgeva was superior to Zometa for delaying skeletal related events (SRE’s) that include bone fractures, pain or spinal compression fractures – 21 months versus 17 months. The average time it took for SRE occurrence was 26 months for breast cancer patients and not yet reached with Xgeva. The study included 5700 patients.

According to Amgen, the manufacturer of Xgeva, “A diagnosis of bone metastases is a major event for patients living with cancer, and the consequences can be devastating. We are pleased to offer this new advance to patients and their healthcare providers." Unlike Zometa, the drug is not approved for patients with multiple myeloma.

They also note that more than 70 percent of men with prostate cancer are lacking treatment for bone fractures. Xgeva is given once a month under the skin, making it easier for urologists to administer, compared to intravenous Zometa.