FDA Announces New Drug for Advanced Prostate Cancer

The Food and Drug Administration (FDA) approved a new drug Wednesday designed to treat men with metastatic, castration-resistant prostate cancer that has spread to bones but not to other organs.

In particular, according to the FDA, the drug is intended for men whose cancer has spread despite medical or surgical therapy to lower testosterone.

The medication, called Xofigo, works by binding with minerals in the bone to deliver radiation directly to bone tumors, thus limiting the damage to the surrounding normal tissues, according to Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

It is the second prostate cancer drug approved by the FDA in the past year that has shown the ability to extend the life of men with metastatic prostate cancer, the last one being Xtandi, which was approved in August 2012.

According to the FDA, the new drug’s safety and efficacy were evaluated in a single clinical trial of 809 men diagnosed specifically with castration-resistant prostate cancer that showed evidence of having spread to bones but not other organs, a random selection of which received the medication and the others a placebo.

In all, those men who received Xofigo lived a median of 14 months compared to a median of 11.2 months for those who received the placebo.

The most common side effects reported were nausea, diarrhea, vomiting and swelling of the leg, ankle or foot.

Prostate cancer develops in the gland in the male reproductive system located below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow.

According to the National Cancer Institute, an estimated 238,590 men will be diagnosed with prostate cancer in 2013, of which 29,720 will die.