XinlayTreatment for Prostate Cancer
Abbott Submits New Drug Application to U.S. FDA for Advanced Prostate Cancer Drug, Xinlay (atrasentan)
ABBOTT PARK, Ill., December 14, 2004 -- Abbott announced today it has submitted a New Drug Application (NDA) for its oral agent Xinlay (atrasentan), to the U.S. Food and Drug Administration (FDA) seeking approval of Xinlay for the treatment of metastatic hormone-refractory prostate cancer, an advanced stage of the disease that no longer responds to hormone treatment and has spread to other parts of the body, such as the bone.
"The submission of this New Drug Application is an important milestone in Abbott's commitment to prostate cancer patients and their families," said John Leonard, M.D., vice president, Global Pharmaceutical Development at Abbott. "Our novel pipeline for drug development has the potential to address many critical health issues for patients and we are committed to developing targeted therapies that are less toxic."
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.
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.
For the thousands of patients whose prostate cancer spreads to other organs, the disease remains incurable. For these patients, treatment options are limited and many patients no longer respond to hormone therapy. The cancer in hormone-refractory prostate cancer patients often spreads to their bones and patients are left with few treatment options. Bone pain from metastases is one of the more disabling manifestations of advanced prostate cancer.
"Hormone-refractory prostate cancer has a profound impact on the lives of men with advanced prostate cancer," said Joel Nelson, M.D., professor and chairman of Urology at the University of Pittsburgh School of Medicine and clinical trial investigator. "Novel therapies represent hope for all prostate cancer patients and their families."
"Men with advanced prostate cancer and their families seek information and support and do not give up their search for new effective treatment options. We are always pleased to see new developments in prostate cancer treatment," said Thomas Kirk, president and CEO of Us TOO International Prostate Cancer Education and Support Network.
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(TM)). SERAs antagonize the effect of endothelin -1 (ET-1), 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.
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 angiogenesis (new blood vessel formation), signal transduction and programmed cell death (apoptosis).
Abbott currently markets tests for detection of cancer, including a PSA test. Abbott's innovative genomic tests include Vysis(R) Urovysion(TM), for monitoring the recurrence of bladder cancer, and PathVysion(R), 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 55,000 people and markets its products in more than 130 countries.
For further information about atrasentan (Xinlay), please visit www.abbott.com
Posted: December 2004
- FDA Advisory Committee Does Not Recommend Approval of Xinlay (atrasentan) - September 13, 2005
- FDA Agrees to File Abbott's New Drug Application for Xinlay (Atrasentan) to Treat Metastatic Hormone-Refractory Prostate Cancer - February 11, 2005