FDA NEWS
Clinical Oncology News • JANUARY/FEBRUARY 2009
Degarelix Approved for Prostate Cancer
Hypothalamus GnRH
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he FDA has approved degarelix (Ferring Pharmaceuticals), an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of advanced prostate cancer. Potential trade names are still under review with the FDA. Phase III trials showed that degarelix is at least as effective as leuprolide (Lupron Depot, Abbott Laboratories) in sustaining castrate levels or lower of testosterone, and resulted in a statistically significant faster reduction of testosterone. By day 3 of treatment, 96% of patients receiving degarelix achieved castrate levels of testosterone, compared with
Anterior Pituitary Gland
FSH, LH Testis Prostate Gland
Hormonal regulation of the prostate gland Academy GmbH & Co. KG Provided by www.prostatecancerliving.com
see FDA NEWS, page 15
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Advisory Board Bioethics Joseph P. DeMarco, PhD, Professor Emeritus of Philosophy, Department of Philosophy, Cleveland State University, Cleveland, OH Paul J. Ford, PhD, Associate Staff in Bioethics and Neurology, The Cleveland Clinic Foundation; Assistant Professor, Cleveland Clinic Foundation Lerner College of Medicine of Case Western Reserve University, Cleveland, OH
Community Oncology John W. Finnie, MD, Staff Hematologist and Medical Oncologist, David C. Pratt Cancer Center, St. John’s Mercy Medical Center, St. Louis, MO
Hematologic Malignancies Jennifer R. Brown, MD, PhD, Attending Physician, CLL & Lymphoma Program, Dana-Farber Cancer Institute; Assistant Professor of Medicine, Harvard Medical School, Boston, MA Agnes Y.Y. Lee, MSc, MD, Associate Professor, Department of Medicine, McMaster University; Consultant, Thromboembolism Service, Hamilton Health Sciences Henderson General Hospital, Hamilton, Ontario Richard Stone, MD, Clinical Director of the Adult Acute Leukemia Program, Dana-Farber Cancer Institute; Associate Professor of Medicine, Harvard Medical School, Boston, MA
Oncology Nursing Betty Ferrell, RN, PhD, Research Scientist, City of Hope National Medical Center, Duarte, CA
Pharmacy Polly E. Kintzel, PharmD, Clinical Pharmacy Specialist—Oncology, Spectrum Health Hospitals, Grand Rapids, MI Melvin E. Liter, MS, PharmD, Liter Enterprises, Liter Consulting Services, Lexington, KY
Policy and Management Mary Lou Bowers, MBA, President and CEO, Barbara Constable, RN, MBA, Director,
Testosterone
0% receiving leuprolide. By day 14, 99% of patients receiving degarelix achieved castrate levels of testosterone, compared with 18% receiving leuprolide. In the clinical trial, prostate-specific antigen (PSA) levels were also monitored as a secondary end point. PSA levels were reduced by 64% two weeks after administration of degarelix; 85% after one month; 95% after three months; and remained suppressed throughout the one-year period of treatment. These results should be interpreted with caution because of the heterogeneity of the patient population studied. There is no evidence showing that the rapidity of PSA decline is related to a clinical benefit.
Rhonda M. Gold, RN, MSN, Director, The Pritchard Group, LLC, Rockville, MD
Solid Tumors Bone Metastases Allan Lipton, MD, Professor of Medicine and Oncology, Milton S. Hershey Medical Center, Penn State University, Hershey, PA
Breast Cancer Andrew Seidman, MD, Attending Physician, Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center; Associate Professor, Weill Cornell Medical College, New York, NY
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Gynecologic Cancer
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