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ENZAMET Trial: Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer

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San Francisco, CA USA (UroToday.com) -- Astellas Pharma Inc. and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the filing of a supplemental New Drug Application (sNDA) for XTANDI®(enzalutamide) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC).
BACKGROUND: Enzalutamide, an androgen-receptor inhibitor, has been associated with improved overall survival in men with castration-resistant prostate cancer. It is not known whether adding enzalutamide to testosterone suppression, with or without early docetaxel, will improve survival in men with metastatic, hormone-sensitive prostate cancer.
Conference Coverage
Conference Highlights from Recent Conference Coverage
Presented by Ian Davis, MBBS, PhD, FRACP, FAChPM
The 2020 Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) Mini Annual Scientific Meeting featured a session on ANZUP trial updates, including an update of the critical Phase III ENZAMET trial provided by Drs. Ian Davis, Arun Azad, and Lisa Horvath.
Presented by Neal D. Shore, MD, FACS
Dr. Shore from the Carolina Urologic Research Center presented a plenary talk discussing the multitude of hormonal treatment options for patients with metastatic castration sensitive prostate cancer (mCSPC). Dr. Shore began by highlighting data from Dr. Huggins seminal work demonstrating that prostate cancer is hormone dependent.
Presented by Alicia Morgans, MD, MPH
San Francisco, California (UroToday.com) Dr. Alicia Morgans, Associate Professor and Medical Oncologist at Northwestern University Feinberg School of Medicine, presented some of the most influential articles from the past year in the field of prostate cancer research from a medical oncology perspective.
Presented by Henrik Gronberg, MD, PhD
Barcelona, Spain (UroToday.com) At the prostate cancer poster discussion at ESMO 2019, Dr. Henrik Gronberg provided a discussion of three important abstracts: the updated STAMPEDE “M1|RT Comparison”, as well as patient reported outcomes from both ENZAMET and TITAN.
Presented by Martin R. Stockler, MBBS(Hons) MSc(Clin Epi) FRACP
Barcelona, Spain (UroToday.com)  At 2019 ASCO meeting, Davis and colleagues previously reported that treatment with enzalutamide rather than an older non-steroidal anti-androgen (bicalutamide, nilutamide, or flutamide), resulted in longer overall survival 
Presented by Tanya B. Dorff, MD
Chicago, IL (UroToday.com) The presentation of ENZAMET, overall survival (OS) results of a phase III randomized trial of standard-of-care therapy with or without enzalutamide for metastatic hormone-sensitive prostate cancer (mHSPC): ENZAMET (ANZUP 1304), an ANZUP-led international cooperative group trial, by Christopher Sweeney, MBBS, was followed by Tanya B. Dorff, MD, of City of Hope Cancer Center,
Presented by Christopher Sweeney, MBBS
Chicago, IL (UroToday.com) Abiraterone and docetaxel are both standard of care options for available for patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the United States. 
Presented by Christopher Sweeney, MBBS
Chicago, IL (UroToday.com) Testosterone suppression is the backbone of treatment for metastatic hormone-sensitive prostate cancer (mHSPC), however, until 2014, testosterone suppression +/- standard nonsteroidal antiandrogen was the only therapy available. 

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