A new prostate cancer drug developed by Medivation, Inc and Astellas Parma Inc was approved by the U.S. Food and Drug Administration, the agency announced on Friday.
The drug, called Ztandi or enzalutamide, was approved to treat men with late-stage (metastatic) prostate cancer who have already received hormone therapy and chemotherapy. The pill is also being test on patients with early stage prostate cancer, Reuters reported.
Ztandi is part of a new group of drugs called androgen inhibitors, which interfere with the ability of testosterone to stimulate prostate cancer cell growth, according to Reuters. The FDA stated that prostate cancer forms in a gland in the male reproductive system and is stimulated by testosterone.
In a statement released Friday, Dr. Richard Pazdur, the director of hematology and oncology products at the FDA's drug evaluation and research center, said, "The need for additional treatment options for advanced prostate cancer continues to be important for patients. Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient's life.
The FDA stated that the average survival for patients receiving Xtandi was 18.4 months and 13.6 months for patients who received the placebo.
According to Reuters, the FDA approved Johnson & Johnson's Zytiga, designed to work inside cancer cells to block testosterone production, last year. The FDA reported that the National Cancer Institute estimates 241,740 men will be diagnosed with the disease and 28,170 will die from it in 2012 alone.
Medivation announced that it would begin selling Ztandi in mid-September and told Reuters that it would sell the drug at a wholesale price of $7,450 for a 30-day supply.
The study found that the most common side effects found in patients taking Ztandi were weakness, back pain, upper respiratory infections and dizziness. Reuters said the FDA reported seizures occurred in less than 1 percent of patients and that post-marketing studies to determine the seizure risk were required.
Dr. E. David Crawford, head of the urological oncology department at the University of Colorado Health Sciences Center and chairman of the Prostate Conditions Education Council, told Reuters, "I am confident that this is only the beginning of success stories with this agent and that it will be used in earlier stages of prostate cancer in the near future."
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