(dailyRx News) A new drug - Xtandi (enzalutamide) - has been approved by the U.S. Food and Drug Administration to treat advanced prostate cancer. In clinical trials, it gave men about five more months of life.
The drug treats men with prostate cancer that has returned, has spread and no longer responds to treatment. Prostate cancers that can't be treated are called castration-resistant.
Xtandi is designed for men who have been treated with a chemotherapy agent called docetaxel.
The medication has been under the FDA’s priority review program, which speeds up the approval process for drugs that offer either have no treatment options or drugs that provide major treatment advances. The FDA approved this one three months early.
“The need for additional treatment options for advanced prostate cancer continues to be important for patients,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient’s life.”
This approval comes after clinical trials involving nearly 1,200 patients with castration-resistant prostate cancer who had been treated with docetaxel. The object of the study was to compare how long men taking Xtandi lived compared to men taking a placebo.
Men treated with the drug lived a median (middle) of 18.4 months, while those receiving a placebo lived 13.6 months.
Side effects of Xtandi seen in the study included fatigue, back pain, diarrhea, joint pain, hot flush, tissue swelling, musculoskeletal pain, headache, upper respiratory infections, dizziness, spinal cord compression and cauda equina syndrome, muscular weakness, difficulty sleeping, lower respiratory infections, blood in urine, tingling sensation, anxiety and high blood pressure.
About 1 percent of those receiving Xtandi had a seizure, at which point they stopped the medication. Men with certain brain disorders were exclude from the study.
Patients in the study who had a seizure stopped Xtandi therapy. The clinical study excluded patients with neurological conditions.
These conditions include: a history of seizure, 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, an abnormal connection of the arteries and veins in the brain, or patients taking medications that may lower the seizure threshold.
The safety of Xtandi is unknown in patients with these conditions, according to the FDA.
Xtandi will be co-marketed by Astellas Pharma U.S. and Medivation, Inc.