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Novel Therapy Zytiga Approved by FDA for Metastatic Prostate Cancer

March 9, 2012 -- Zytiga® (abiraterone acetate) was approved by the US Food and Drug Administration in April 2011 for the treatment of metastatic castration-resistant prostate cancer (mCRPC), following docetaxel chemotherapy. Zytiga® does not have FDA approval for use in patients with advanced disease who have not received chemotherapy.

The effects of this medication are currently being tested in prostate cancer patients with asymptomatic or minimally symptomatic mCRPC, in a Phase III clinical trial. This international, double-blind, placebo-controlled study called Cougar 302 was conducted by the Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

A planned interim analysis of the Cougar 302 trial today reported patient clinical benefit in terms of radiographic progression-free survival and overall survival. Based on this clinical finding, the Independent Data Monitoring Committee (IDMC) has unanimously recommended unblinding the Cougar 302 clinical trial, allowing patients on the placebo arm to be offered treatment with Zytiga®. Janssen R&D plans to apply for regulatory approval for Zytiga® in this subset of prostate cancer patients in the second half of 2012.

PCF has invested more than $9 million in support for the development of this new drug, which was provided via competitively-selected, non-corporate academic grants for research related to Abiraterone starting in 2006. In 2007, Peter Nelson, MD, a PCF-funded research at the University of Washington and the Fred Hutchinson Cancer in Seattle, first discovered the mechanism of action of Abiraterone, which was initially developed by scientists at the Institute of Cancer Research (ICR) in the UK. Dr. Nelson’s findings sparked additional PCF funding in the form of two Challenge Awards and two Young Investigator Awards granted to researchers in his department.

In addition, the Prostate Cancer Clinical Trials Consortium, funded jointly by PCF and the U.S. Department of Defense at M. D. Anderson Cancer Center, Memorial Sloan-Kettering Cancer Center and Dana-Farber Cancer Institute, performed early clinical investigations of Abiraterone that accelerated the development of this promising medication.

“We are grateful to every researcher in the PCF family whose expertise touched the development of Abiraterone,” said Howard Soule, chief scientist and executive vice president for PCF. “Moreover, we are thankful for the global clinical development efforts of Howard Scher, MD (Memorial Sloan-Kettering, New York), and Johann De Bono, MD (The Royal Marsden Hospital, London), who led the phase III investigation for Abiraterone.”

For more on Zytiga, read the Janssen Research & Development media release.

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