FDA Approves Xtandi
FOR IMMEDIATE RELEASE
Prostate Conditions Education Council Applauds FDA Priority Review and Approval
Leading PROSTATE CANCER GROUP SAYS New drug GIVES HOPE TO MEN WITH ADVANCED prostate cancer
The Prostate Conditions Education Council (PCEC), applauds today’s approval by the United States Food and Drug Administration (FDA) of a groundbreaking new therapy, Xtandi. The drug has shown promise in clinical trials, extending the life of men with advanced prostate cancer even following other treatments.
“This new therapy represents an important advancement in the treatment of prostate cancer, extending survival in patients who failed previous chemotherapy for castration-resistant disease,” said Daniel Petrylak, M.D., PCEC council member and director of the genitourinary oncology program and co-director of the signal transduction program at the Yale University Cancer Center.
The PCEC, a national organization committed to men’s health and a leader in supporting prostate cancer research and treatment, has been working for several decades to improve treatment options. New treatments like Xtandi- an antiandrogen therapy that acts to block testosterone, slowing prostate cancer growth - are bringing new hope to men with prostate cancer.
"Since our work with antiandrogens began over two decades ago, we have been waiting for a superior agent that shows promise for late-stage patients; today we have it with the approval of Xtandi,” said E. David Crawford, M.D. head of the urologic oncology department at the University of Colorado Health Sciences Center, and founder/chairman of the PCEC. “I am confident that this is only the beginning of success stories with this agent and that it will be used in earlier stages of prostate cancer in the near future. While this therapy is an innovative development for patients in the late stages of prostate cancer, early detection and treatment are key to survival. Continued efforts to improve awareness and education of the disease are still very important and support efforts to diagnose and treat the disease before it reaches the advance stages.”
Prostate cancer remains the second leading cause of cancer death among American men[i], and can be an aggressive disease that is most successfully treated when detected early on. Each year, the PCEC holds Prostate Cancer Awareness Week, dedicated to offering free or low-cost screenings for more than 125,000 men across the U.S. and internationally. This year, the week is being held September 16-22. Since the first PCAW in 1989, the program has helped to screen nearly five million men in the U.S., and this number continues to grow each year both at home and internationally.
About the Prostate Conditions Education Council
A national organization committed to men’s health, the Prostate Conditions Education Council (PCEC) is the nation’s leading resource for information on prostate health. The PCEC is dedicated to saving lives through awareness and the education of men, the women in their lives, as well as the medical community about prostate cancer prevalence, the importance of early detection, and available treatment options, as well as other men’s health issues. The Council – comprised of a consortium of leading physicians, health educators, scientists and prostate cancer advocates – aims to conduct nationwide screenings for men and perform research that will aid in the detection and treatment of prostate conditions. More information is available at www.prostateconditions.org.
Xtandi, formerly known as Enzalutamide or MDV3100, is an oral, once-daily agent that is an androgen receptor signaling inhibitor. Xtandi inhibits androgen receptor signaling in three distinct ways: it inhibits 1) testosterone binding to androgen receptors; 2) nuclear translocation of androgen receptors; and 3) DNA binding and activation by androgen receptors. In the Phase 3 AFFIRM trial common side effects observed more frequently in Xtandi as compared with placebo-treated patients included fatigue, diarrhea and hot flush. Seizure was reported in less than 1% of Xtandi-treated patients. Serious adverse events, adverse events causing patients to stop treatment, and adverse events causing death all were lower in the Xtandi group than in the placebo group.
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