The FDA has approved radium Ra 223 dichloride (Xofigo, Bayer) to treat men with metastatic castration-resistant prostate cancer, who have not responded to medical or surgical therapy to lower testosterone, after the cancer has spread to bones but not other organs.
The approval comes three months ahead of schedule under the agency’s priority review program, which expedites the review process for therapies when no satisfactory alternative exist, or if the treatment offers significant improvement to products already on the market.
In 2013, more than 200,000 men will be diagnosed with prostate cancer and 29,790 will likely die from the disease, according to National Cancer Institute estimates.
“Xofigo binds with menerals int he bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues,” Richard Pazdur, MD, director of the FDA’s Center for Drug Evaluation and Research Office of Hematology and Oncology Products.
Results from a single clinical trial involving 809 men with symptomatic castration-resistant prostate cancer showed that patients assigned to treatment with radium Ra 223 dichloride lived a median of 14 months vs. 11.2 months for patients assigned to placebo plus standard of care, and that the medication has the ability to extend overall survival.
Common sided effects include nausea, diarrhea, vomiting and swelling of the leg, ankle or foot. Blood abnormalities, such as anemia, lymphocytopenia, leukopenia, thrombocytopenia and neutropenia, may also occur.
Radium Ra 223 dichloride is the second treatment the FDA has approved in the past year to extend survival in men with metastatic prostate cancer. Xtandi was approved in 2012 for use in metastatic prostate cancer patients who have previously underwent medical or surgical therapy, and who have received the chemotherapy drug docetaxel.