Prostate Cancer Awareness Month: USDA Approves New Treatment Which "May Offer Major Advances In Treatment" For Patients

On Friday, the USDA approved Xtandi, a new treatment for men with late-stage (metastatic) castration-resistant prostate cancer. Xtandi has been approved for patients who have been treated with docetaxel previously, and was green-lighted three months ahead of its goal date of Nov. 22, 2012.  According to the FDA, the drug "may offer major advances in treatment or provide a treatment where no adequate therapy exists."

Richard Pazdur, director of the Office of Hematology and Oncology Products at the FDA expressed that "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," he added.

Prostate cancer affects 230,000 men annually, and is diagnosed about every 2.6 minutes in the United States. The National Cancer Institute predicts that 241, 740 men will be diagnosed with the cancer in 2012, and 28,170 of them will die of the disease the same year. The cancer afflicts a gland in the male reproductive system that is located below the bladder and in front of the rectum

The FDA's statement reveals that the drug was tested on 1,199 patients who have previously been treated with docataxel. Men who received Xtandi typically extended their life by an average of 4.8 months, with Xtandi patients receiving 18.4 months, and placebo patients living for 13.6 months from the study's start date.

Side effects include: weakness, fatigue, back pain, diarrhea, joint pain, hot flush, tissue swelling, musculoskeletal pain, headache, upper respiratory infections, dizziness, spinal cord compression and cauda equine syndrome, muscular weakness, difficulty sleeping, lower respiratory infections, blood in urine, tingling sensation, anxiety, and high blood pressure. Additionally, 1 percent of Xtandi patients experienced seizures.

Those excluded from the drug include patients with a history of the following health problems: seizures, an underlying brain injury with loss of consciousness, a temporary decrease in blood to the brain within the past 12 months, a stroke, brain metastases, or an abnormal connection of the arteries and veins in the brain.