This has been an interesting year as men with advanced prostate cancer have seen three different drugs approved. Considering that the prior six years did not have any new drug approvals, this has been a stellar year.

First we had Provenge approved, then came Jevtana and now we have added to the list Xgeya (denosumb).

Men with advanced prostate cancer and bone metastases have had only one drug to fight the development of skeletal events that accompany the mets. Skeletal events for men with prostate cancer are one of the most serious complications that we face. Now, with the approval Xgeva, we have a second drug (Zometa is the only other approved drug) to look to for fighting these problems. Xgeva protects against skeletal-related events, fractures and bone pain in men with advanced prostate cancer.

Xgeva works differently than the bisphonate Zometa. Xgeva, a monoclonal antibody, targets human RANKL. Human TANKL is a protein involved in the destruction of the bones in men with cancer.

Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said:
“Bone metastases represent a major cause of pain and suffering in patients with cancer and can affect a patient’s quality of life. Xgeva has a different mechanism of action than currently approved drugs aimed at reducing bone complications from cancer.”

Three randomized, double-blind clinical trials involving 5,723 participants which compared Xgeva with Zometa for safety and effectiveness. Xgeva was found by the FDA to be both safe and effective. One of the studies was with breast cancer patients, another with prostate cancer, and the other involved patients with several different types of cancers.

The studies measured how long it took for a fracture or cord compression to occur as well as length of time before radiation or surgery to treat bone pain was required.

Xgeva was found to be better than Zometa in delaying skeletal related events (SREs) in breast and prostate cancer patients. Among the prostate cancer participants taking Xgeva, the average time was 21 months, compared to 16 months for those on Zometa.

So, talk to your doctor about taking Xgeva instead of Zometa when bone metastases develop.

Joel T Nowak, M.A., M.S.W.