FDA Advisory Committee Does Not Recommend Approval of Xinlay (atrasentan)
Abbott Park, Illinois, September 13, 2005 -- Abbott announced today that the Oncology Drug Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) did not recommend approval of the oral investigational agent Xinlay (atrasentan) for the treatment of patients with hormone-refractory prostate cancer (HRPC) that has spread to the bone.
"Eighty-five percent of the men with hormone-refractory prostate cancer have disease that spreads to the bone," said Joel Nelson, M.D., professor and chairman of urology, University of Pittsburgh School of Medicine. "Debilitating bone pain is the cardinal symptom of this stage of the disease and there are currently limited choices to delay this in men."
"Abbott respects the committee's vote on Xinlay today; however, we continue to believe that Xinlay represents an important option for patients with advanced prostate cancer who currently have limited options," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "The company is encouraged by committee member statements regarding the activity of Xinlay and the value of continuing development of the drug. We await FDA's decision on Xinlay."
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 (SERAÂ). SERAs antagonize the effect of endothelin-l (ET-l), one of the proteins thought to be involved in the stimulation of the growth and spread of cancer cells. Abbott submitted a New Drug Application (NDA) in December 2004 seeking approval. The NDA for Xinlay supplied data on time to disease progression and delay in time to onset of bone pain.
Xinlay is being studied in earlier stage prostate cancer patients in an ongoing Phase III study in hormone-refractory prostate cancer patients without metastasis. This study is expected to be completed in 2006.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 60,000 people and markets its products in more than 130 countries.
Previously:
FDA Agrees to File Abbott's New Drug Application for Xinlay  (Atrasentan) to Treat Metastatic Hormone-refractory Prostate Cancer. February 11, 2005
Atrasentan, renamed Xinlay™: Abbott seeks FDA Approval ... Dec 14 2004
Atrasentan/Xinlay™ Update: "Meta-analysis" says patients had less disease progression and less pain May 26, 2005 (ASCO)
