FDA Approves New Drug 'Xofigo' to Treat Prostate Cancer

A new drug 'Xofigo' has been approved by the U.S. Food and Drug Administration to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has attacked the bones but not other organs.

Bayer and Algeta's drug  'Xofigo' (radium Ra 223 dichloride) is meant for men in who the cancer has spread after undergoing medical and surgical therapy to lower testosterone levels.

Data according to the National Cancer Institute suggests that nearly 238,590 men will be diagnosed with prostate cancer, and nearly 29,720 men will die from the disease this year.

"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a press statement. "Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer."

Prior to this, in 2012 a drug called Xtani was approved to treat men with metastatic castration-resistant prostate cancer. It was approved for men who had been previously treated with chemotheraphy drug docetaxel.

To check the safety of the new drug, a single clinical test was conducted on 809 men with symptomatic castration-resistant prostate cancer. The patients were either given a placebo or Xofigo. Researchers noticed that men who received Xofigo lived a median of 14 months, compared to 11.2 months for those receiving the placebo.

The side effects of the new drug include nausea, diarrhea, vomiting and swelling in the leg, foot and ankle.