FDA is Reviewing New Treatment, Xinlay (atrasentan) NOTE: October, 2005 The FDA unanimously denied approval for Xinlay for the treatment of prostate cancer.A biological therapy for the treatment of metastatic prostate cancer, Xinlay (atrasentan), is under review by the FDA and could be approved toward the end of year or early in 2006. Details of this study were reported by Drs. Nicholas Vogelzang (see below), Joel Nelson, etc. at the recent ASCO Prostate Cancer Symposium. Their data showed that in men with metastatic, hormonerefractory prostate cancer, Xinlay appeared to slow the biochemical progression of the disease, delayed the time to onset of bone pain and decreased the incidence of bone pain, and produced an improvement in quality of life. Biological therapy involves using naturally occurring compounds that increase the body's natural immune defenses or interrupt the unnatural growth patterns of cancer cells. The objective of this study was to more precisely define the clinical benefit of atrasentan 10mg in this patient population. Significant to patient consideration is the fact that this novel cytostatic agent could provide measurable benefit in reducing the time to disease progression, which is key to a patient population that had limited treatment options heretofore. Coupled with this are the results showing less likelihood of experiencing bone pain. Bone pain from metastases is one of the more disabling manifestations of advanced prostate cancer. It may severely affect quality of life, causing pain, increased risk of fractures, and other life-threatening complications. Xinlay 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 (SERAs). These agents are being investigated because of their potential to block endothelin activity, which is thought to be involved in the spread of cancer cells. In studies separate from the Phase III clinical trial, Xinlay is currently being studied in several stages of prostate cancer. Trials are ongoing in men with prostate cancer that has not spread (non-metastatic), as well as in men with rising prostate specific antigen (PSA) following prostate cancer surgery. It is also being evaluated in combination trials with approved treatments for advanced prostate cancer. Based on press releases from Abbott Laboratories and Journal of Clinical Oncology, and also 2004 ASCO Annual Meeting Proceedings. Last updated June 2005 |