DOI: 10.1097/01.COT.0000421358.80517.10
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Issn Print: 0276-2234
Publication Date: 2012/09/25
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Excerpt
The drug, which had been approved for prostate cancer patients previously treated with docetaxel, was reviewed under the FDA's priority review program, which provides for an expedited six-month review for drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists.
Xtandi received FDA approval three months ahead of the product's prescription drug user fee goal date of November 22.
“The need for additional treatment options for advanced prostate cancer continues to be important for patients,” Richard Pazdur, MD, Director of the FDA's Office of Hematology and Oncology Products, said in a statement. “Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient's life.”
The drug's safety and effectiveness were evaluated in a study of 1,199 patients with metastatic castration-resistant prostate cancer who had received prior treatment with docetaxel. The study was designed to measure overall survival in men receiving Xtandi compared with men receiving a placebo.
The median overall survival for patients receiving Xtandi was 18.4 months, compared with 13.6 months for those receiving placebo.
The most common side effects for patients receiving Xtandi were weakness/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, hematuria, tingling sensation, anxiety, and high blood pressure.
Seizures occurred in about one percent of those receiving Xtandi, and the drug was stopped in those patients. The study excluded patients with a history of seizure or who had 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 were taking medications that could lower the threshold of seizures. The safety of Xtandi is unknown in patients with these conditions, a news release notes.
The drug will be co-marketed by Astellas Pharma and Medivation.
