FDA agrees to file Abbott's new drug application for Xinlay(reg) (atrasentan) for metastatic hormone-refractory prostate cancer

Main Category: Cancer / Oncology
Also Included In: Prostate / Prostate Cancer
Article Date: 13 Feb 2005 - 8:00 PDT

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Abbott announced today that the U.S. Food and Drug Administration (FDA) has agreed to file the New Drug Application (NDA) for its oral agent Xinlay(reg) (atrasentan) for the treatment of metastatic hormone-refractory prostate cancer. This action by the FDA indicates the NDA is sufficiently complete to permit a substantive review of the data supporting Xinlay's safety and effectiveness. Abbott expects a response from FDA regarding its application in the fourth quarter of 2005.

Abbott's NDA for Xinlay is based on Phase II and III clinical trials in men with metastatic hormone-refractory prostate cancer. The NDA submission supplies data regarding the effect of Xinlay on disease progression and delay in time to onset of bone pain.

"The FDA acceptance of an application is a critical step in our goal of making new therapies that are less toxic available to patients," said John Leonard, M.D., vice president, Global Pharmaceutical Development at Abbott. "For patients whose prostate cancer spreads to other organs, prostate cancer remains incurable. The cancer in hormone-refractory prostate cancer patients often spreads to their bones and patients are left with few treatment options."

Among American men, prostate cancer is the second most common cancer, after skin cancer, and is the second leading cause of cancer death. This year in the United States, an estimated 230,000 men will be diagnosed with prostate cancer, and 30,000 will die from the disease. The incidence of prostate cancer is expected to increase to more than 300,000 annually over the next decade, as baby boomers begin to reach the target age for detection.

About Xinlay

Xinlay is an investigational, oral, once-daily, non-hormonal, non-chemotherapy, anti-cancer agent that belongs to a class of compounds known as selective endothelin-A receptor antagonists (SERA(reg)). SERAs antagonize the effect of endothelin - l (ET-l), one of the proteins thought to be involved in the stimulation of the spread of cancer cells.

Xinlay is currently being studied in several stages of prostate cancer. Trials are ongoing in men with hormone-refractory prostate cancer that has not spread (non-metastatic), as well as in hormone-naive men with rising prostate-specific antigen (PSA) following prostate cancer surgery. Additionally, Xinlay is being evaluated in combination trials with approved treatments for advanced prostate cancer. Abbott continues to explore Xinlay in other cancers, including kidney, ovarian, brain and non-small-cell lung cancers. Data from Xinlay clinical trials will be made available at scientific sessions this spring.

About Abbott

Abbott is committed to the discovery and development of innovative treatments to help patients in the fight against cancer. Abbott's oncology research is focused on developing targeted, less toxic therapies. The company has several different classes of compounds in various stages of clinical development. These approaches address multiple phases of cancer progression, including signal transduction, angiogenesis (new blood vessel formation) and programmed cell death (apoptosis).

Abbott currently markets tests for detection of cancer, including a PSA test. Abbott's innovative genomic tests include Vysis(reg) UroVysion(reg), for monitoring the recurrence of bladder cancer, and PathVysion(reg), for detecting the HER-2 gene, which predicts potential treatment benefit in women with breast cancer. Abbott also markets nutritional products designed to meet the unique dietary needs of cancer patients.

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.

For further information about atrasentan (Xinlay), call (800) 633-9110.
abbott.com/news/press_release

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