FDA Approves Xofigo for Advanced Prostate Cancer

The US Food and Drug Administration (FDA) has approved Xofigo (radium-223 dichloride) to treat certain men with advanced prostate cancer. It is intended for men whose cancer has spread (metastasized) only to their bones and who have already received treatment to lower testosterone. Because testosterone can cause prostate cancer to grow, the goal of some surgery and drug treatments is to lower the level of this male hormone in the body. When the cancer spreads or comes back after such treatment, it’s sometimes called castration-resistant.

The FDA reviewed Xofigo under its priority review program for drugs. The program is designed to get faster approval for drugs that appear to provide safe and effective treatment when no other satisfactory treatment exists, or offer a significant improvement over the existing treatments.

The agency based its decision on a clinical trial of 809 men with castration-resistant prostate cancer that had spread to their bones, but not to other organs. Results showed men who received Xofigo lived an average of 14 months compared to just over 11 months for men who received a placebo injection.

“Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Xofigo is given as injection into a vein, once a month. The most common side effects in studies of the drug have been nausea, diarrhea, vomiting, and swelling of the leg, ankle, or foot. The most common abnormalities detected during blood testing included low levels of red blood cells (anemia), lymphocytes (lymphocytopenia), white blood cells (leukopenia), platelets (thrombocytopenia) and infection-fighting white blood cells (neutropenia).

Xofigo is marketed by Bayer Pharmaceuticals.

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