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Xtandi Receives FDA Approval for Prostate Cancer Patients

New Drug Supported with Early Funding from the Prostate Cancer Foundation Represents New Treatment for Advanced Disease

August 31, 2012 -- Xtandi, formerly known as MDV3100, today received approval from the U.S. Food and Drug Administration (FDA). This drug is a new-generation anti-androgen treatment that can prolong life for men who have failed hormone and chemo therapies. Support from the Prostate Cancer Foundation (PCF) through every step of development—from idea through clinical trials—helped this new drug make its way to treatment-resistant patients in a comparatively short timeframe.

“The discovery of Xtandi started with a pilot grant to university scientists with a bigger and more novel idea that pharmaceutical companies had missed. Now Xtandi is a new molecule for treating patients,” commented Jonathan W. Simons, president and CEO of PCF. “This hardly ever happens. When it does, it reminds us how much more might be done by unleashing creativity.”

“We are so pleased to see the approval of Xtandi for patients who are in need of new drugs for advanced disease. Together with Zytiga (abiraterone), which was approved in April of last year, we now have an expanded arsenal of tools to prolong and enhance the quality of life for prostate cancer patients,” added Simons.

The development of Xtandi began with a PCF Board of Directors meeting held at UCLA where the world’s top cancer scientists in leukemia were invited to apply for funding and work on prostate cancer. What ensued was a 2002 competitive CaP CURE (PCF) research award to Owen Witte, MD, Michael Jung, PhD, and Charles Sawyers, MD. Michael Jung, a professor in organic chemistry, discovered the compound after working with Dr. Sawyers on the mechanisms of flutamide resistance.

Xtandi has a novel mechanism of action, inhibiting the androgen receptor (AR) at three distinct points in the signaling pathway. The drug directly blocks the activity of the androgen receptor, the engine of prostate cancer progression. In its Phase III clinical study, Xtandi increased median survival by 4.8 months, providing a 37 percent reduction in the risk of death compared to placebo. Some patients have very durable remissions well beyond the average while others do not respond. Thus, the median survival is a statistical description for the FDA and clinical researchers.

The Xtandi clinical trial marks the second time the trial of a prostate cancer drug was stopped early and the drug offered to patients in the placebo arm, due to its effectiveness in causing remissions and high tolerability in patients. The first case was with Zytiga (abiraterone) which was approved in 2011. Zytiga, also supported with funding by PCF, affects prostate cancer progression by shutting off the supply of fuel, testosterone. Having both drugs available to patients represents an important advance in patient treatment.

Xtandi will be distributed jointly by Medivation, Inc. and Astellas Pharma, Inc. On July 24 of this year, Medivation, which developed the UCLA experimental prostate cancer drug, was granted priority review status by the U.S. Food and Drug Administration, potentially reducing the review time by half, based on proven clinical benefits.

Already, both Xtandi and Zytiga are now being evaluated in Phase III trials in patients who have failed hormone therapy but prior to chemotherapy. Results are not yet available, but efforts will concentrate on testing both new drugs in men with early recurrence of disease. Xtandi and Zytiga are also being tested in the pre-surgical setting—prior to prostatectomy—with funding from PCF Challenge Awards, with curative intent for primary high-risk prostate cancer.

The research and development period for Xtandi has been a comparatively short nine years. PCF’s total investment of $14.75 million in this new medication was also supported by the PCF’s investment in the Prostate Cancer Clinical Trials Consortium.

Read more about Xtandi and data results from the phase III AFFIRM trail, featured in OncLive.

About the Prostate Cancer Foundation

The Prostate Cancer Foundation (PCF) is the world’s largest philanthropic source of support for accelerating the most promising research for better treatments and cures for prostate cancer. Founded in 1993, PCF has generated $490 million and provided funding to more than 1,600 research programs at nearly 200 cancer centers and universities in 15 countries. PCF advocates for greater awareness of prostate cancer and more efficient investment of governmental research funds for transformational cancer research. Its efforts have helped produce a 20-fold increase in government funding for prostate cancer. More information about the PCF can be found at

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