The FDA has approved a new drug for the treatment of advanced prostate cancer. It is called Xofigo, radium RA 223 dichloride, and it is meant for the treatment of metastatic, symptomatic late stage prostate cancer that is castration resistant, and has reached bones, but has not gotten to other organs. It is meant for men that have cancer that has spread after they received surgical or medical therapy to help lower testosterone levels.
Prostate cancer starts in the male reproductive glad that is located under the bladder, in front of the rectum. Testosterone, the male sex hormone, stimulates tumors to grow in the prostate. The National Cancer Institute estimates that over 238,000 men will have a prostate cancer diagnosis and over 29,000 will die from it this year alone.
Xofigo has been approved over three months earlier than the “prescription medication user fee goal” of August 14 of this year, which was when the FDA was planning to complete the drug application review. The Federal Drug Administration put Xofigo under the priority review program, which pushed this medication ahead of others as it appeared to be safe and effective therapy for treating prostate cancer when there was no other therapy option.
According to Richard Pazdur, M.D, director of the Office of Hematology and Oncology Products for the FDA’s Drug Evaluation and Research center, “Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues.” He says that Xofigo is the second prostate cancer medication that has been approved by the FDA over the last year that shows an ability to extend the life of men that have metastatic prostate cancer.
The FDA approved a drug called Xtandi in August of 2012 for the treatment of metastatic prostate cancer that is castration resistant and has recurred or spread, even after surgical or medical therapy has been done to reduce testosterone levels. Xtandi has been approved for patients that have been treated with the chemotherapy medication called Deoctaxel.
Xofigo has been evaluated for effectiveness and safety in a clinical trial of more than 800 men that have symptomatic prostate cancer that is castration resistant and has reached the bones, but has not gotten to other organs. Patients were randomly chosen to be given a placebo or Xofigo, as well as the best care possible.
The study measured the overall survival rates of the men taking the drug, and results from the interim analysis showed that men who had been given Xofigo lived an average of 14 months, when compared to men that had been given a placebo and lived for 11.2 months.
Commonly reported side effects of Xofigo during the trials included: diarrhea, nausea, vomiting and swelling of the foot, leg or ankle. The most common problems of blood tests showed anemia, lymphocytopenia, platelet counts, white blood cell counts and the white blood cells that fight infections.