Xtandi for prostate cancer treatment joins the growing list of drugs designed for men who have advanced prostate cancer. On August 31, 2012, the Food and Drug Administration (FDA) approved Xtandi (enzalutamide) for men who have advanced prostate cancer that has spread (metastasized) or recurred despite treatment with hormone therapy and chemotherapy with docetaxel.
Xtandi competes with several other drugs that have been developed to treat advanced prostate cancer. They include:
- Provenge (sipuleucel-T), the only immunotherapy approved by the FDA for treatment of prostate cancer. Provenge has been shown to extend survival by a mean of 4.1 months. Side effects affecting at least 15 percent of men who take Provenge include back pain, chills, fatigue, fever, headache, joint ache, and nausea.
- Zytiga (abiraterone), which is taken along with the steroid prednisone. Zytiga has been shown to extend survival by a mean of 3.9 months. Reported side effects include cough, diarrhea, fluid retention, heartbeat disorders, hot flashes, indigstion, joint swelling, low potassium levels, muscle discomfort, upper respiratory tract infection, urinary frequency, urinary tract infection, and upset stomach.
Xtandi was shown to increase survival longer than the other two drugs: a mean of 4.8 months. Although all three of these prostate cancer treatment can help extend a patient’s life, none of them can cure the disease and all of them come at a considerable cost in both money and side effects.
The FDA approved Xtandi for prostate cancer under an expedited six-month review program , which means it was approved about three months ahead of its original goal of November 22, 2012. Approval was based on the results of a study of nearly 1,200 patients who had hormone-resistant metastatic prostate cancer and who had taken docetaxel.
Xtandi for prostate cancer: study
In the double-blind, placebo-controlled study, men who received Xtandi survived a median of 18.4 months compared with 13.6 months among men who took a placebo. Xtandi, which is co-marketed by Medivation, Inc. and Astellas Pharma US Inc., caused a variety of side effects, including anxiety, back pain, blood in the urine, compression of the spinal cord, diarrhea, dizziness, headache, high blood pressure, hot flush, lower respiratory infections, sleep difficulties, tingling in the extremities, upper respiratory infections, and weakness of the muscles. One percent of the men who took Xtandi experienced seizures.
Men who have metastatic, hormone-resistant cancer now have three drugs they can consider for improved survival. Of the three choices, Provenge is the only immunotherapy option, which means it supports the immune system rather than works to destroy cells. Xtandi does not require the use of prednisone, which is part of the treatment program with Zytiga.
All three drugs also carry a significant price tag, with Xtandi ringing up at $7,450 per month compared with $93,000 for a three-treatment course of Provenge and Zytiga topping $82,000 for a 15-treatment cycle. Men who meet the criteria for these three drugs should discuss the benefits and risks with their healthcare provider and consult their insurance provider before making a treatment decision.
Read more in our Prostate Cancer Health Center.