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Xinlay (atrasentan) is an investigational, oral, once-daily, non-hormonal, non-chemotherapy, agent that belongs to a class of compounds known as selective endothelin-A receptor antagonists developed by Abbott Laboratories. These agents are being investigated because of their potential to block endothelin activity that is involved in the spread of cancer cells.
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Xinlay has fast track review status at the United States Food and Drug Administration (FDA). FDA agreed to file Abbott's New Drug Application (NDA) for Xinlay for the treatment of metastatic hormone?refractory prostate cancer.
Trials are ongoing in men with prostate cancer that has not spread as well as in men with rising prostate specific antigen subsequent to prostate cancer surgery. It is being evaluated in combination trials with agreed treatments for advanced prostate cancer.
Xinlay a selective endothelin-A receptor antagonist has been studied in 2 randomized placebo controlled studies of men with metastatic hormone-refractory prostate cancer (HRPC) using time to disease progression as the primary endpoint. Carducci and team performed a meta-analysis of these studies " to more specifically define the clinical benefit of Xinlay 10 mg in this patient population."
The two studies randomized 1002 men with hormone refractory prostate cancer to obtain either Xinlay 10 mg or placebo. Xinlay 10 mg, according to the researchers, resulted in a statistically major delay in time to progression and time to bone pain, as well as time to prostate specific antigen and bone alkaline phosphatase progression.
Compared with patients receiving placebo, patients treated with Xinlay 10 mg were 14% less likely to experience disease progression, had an 18% less possibility of experiencing bone pain, had a 22% less chance of experiencing PSA progression, and were 46% less likely to experience bone alkaline phosphatase progression.
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