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Food and Drug Administration Approves Abiraterone for Treatment of Men with Advanced Prostate Cancer

Oral Agent Extends Overall Survival by Over Four Months

May 2, 2011 -- The Food and Drug Administration (FDA) on Thursday approved abiraterone, a new targeted therapy in the class of androgen receptor blockers. It improves, by nearly four months, the overall survival rate of men with metastatic chemotherapy- and castration-resistant prostate cancer. Since 2005, the Prostate Cancer Foundation invested $8.2 million in over six research projects to advance independent academic research for investigating abiraterone’s mechanism of action and biomarkers to predict patient response.

In addition, the PCF-Department of Defense Clinical Trials Consortium, along with PCF-funded investigators at the Royal Marsden Hospital in London, were crucial leaders in designing and executing the pivotal Phase III clinical trial that supported the FDA decision to approve the agent.

Sold under brand name Zytiga, the once daily oral treatment blocks the production of testosterone, which can fuel prostate cancer growth and progression, and is the latest breakthrough in treatment options for patients whose cancers have stopped responding to current androgen deprivation therapy (ADT) drugs.

The drug is used for patients with metastatic prostate cancer following docetaxel chemotherapy. Zytiga inhibits CYP17, an enzyme involved in the synthesis of testosterone; it is believed that this mechanism of action results in the observed clinical benefit.

“The prostate cancer community has been anxiously awaiting the FDA’s approval of Zytiga after studying its positive outcomes in Phase I/II and III clinical trials,” said Howard Soule, PhD, executive vice president and chief science officer of the Prostate Cancer Foundation. “For oncologists and their medical teams, Zytiga provides a new standard of treatment care, demonstrating both long-term success and prolonged survival for men with advanced disease.”

PCF applauds the efforts of Howard Scher, MD at Memorial Sloan-Kettering Cancer Center in New York and Johann de Bono, MD, MSc, PhD, FRCP at The Royal Marsden Hospital and the Institute of Cancer Research in London, who designed and led the global Phase III clinical investigation of Zytiga that resulted in FDA approval. Other PCF-funded scientists who were critical to advancing this new drug include Gerhardt Attard, MD, PhD, at The Royal Marsden Hospital and the Institute of Cancer Research and the Royal Marsden Hospital, Peter Nelson, MD, at the Fred Hutchinson Cancer Research Center and Eric Small, MD, at the University of California, San Francisco.

Investigators will continue to work toward improving outcomes for men with advanced prostate cancer and understanding why Zytiga works in some patients, and not in others. It will also be important to understand mechanisms of patient resistance to the agent and how to effectively combine it with existing and new medicines.


About the Prostate Cancer Foundation

The Prostate Cancer Foundation (PCF) is the world’s leading philanthropic organization funding and accelerating research. Founded in 1993, PCF has generated more than $475 million and provided funding to over 1,600 research projects at nearly 200 institutions in 15 countries around the world. PCF advocates for greater awareness of prostate cancer and more efficient investment of governmental research funds supporting transformational cancer research. Our efforts have helped produce a 20-fold increase in government funding for prostate cancer. More information about PCF can be found at pcf.org.

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