Accelerate Progress Comments on Today’s Provenge Data Release

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Accelerate Progress Comments on Provenge Data Released at Annual Meeting of American Urological Association

April 28, 2009

A significant advance for men with advanced prostate cancer was announced today with the release of data from a milestone study on a new immunotherapy called Provenge.  The data from the study, known as IMPACT, supported and confirmed data from two previous Phase III studies and numerous earlier stage trials of the therapy. 

“This data is compelling, exciting, and represents a true paradigm shift in how we think about fighting prostate cancer, “said Scott Riccio, Executive Director of Accelerate Progress.  “For the first time, we have real clinical validation that cancer can be fought by stimulating the body’s immune system and that this approach leads to significant improvements in patient survival, the most meaningful of all measurements.  Hundreds of thousands of men fighting prostate cancer will now have real hope that a safe and effective new option will be available to them in their fight for life.”

“The excitement generated by this data is tinged by sadness, however, in memory of the more than 60,000 men who have already passed away during the two years since the FDA had the opportunity to take the advice of its independent expert panel and approve this new therapy.  Our frustration only increases when we consider that even though this therapy has now exceeded the additional hurdle for approval set for it by the FDA, it will still be another year, another 30,000 deaths, before our system see the therapy approved and broadly available.  This is just one more tragic example of why our drug-to-patient system must be overhauled and modernized, to prevent further unnecessary suffering and death. 

Prostate cancer is the most common cancer, other than skin cancers, in American men is the second leading cause of cancer death in men, behind only lung cancer. The American Cancer Society estimates that during 2008 about 186,320 new cases of prostate cancer were diagnosed in the United States. About 1 man in 6 will be diagnosed with prostate cancer during his lifetime and African-American men are more than twice as likely to die from this disease, for reasons not yet well understood. 

Proponents of earlier access to therapies like Provenge point out they are not advocating a ‘lowering of the scientific bar’ by the FDA, but rather an embrace by the Agency of the science and tools that are available to it for reviewing and approving these therapies, many of which are already shown safe and effective and yet are delayed time and again on technicalities, contributing to tens of thousands of patient deaths each year and significant unnecessary suffering. 

Scott Riccio is founder and executive director of Accelerate Progress, the nonprofit Center to Accelerate Progress Against Cancer and Other Life-Threatening Diseases.

Accelerate Progress works with others to make medical research work better right now for researchers, patients, and clinicians, and to modernize this complex system in the next five years.

Together we find, validate and implement technologies, processes and policies that remove current roadblocks and create new incentives that quickly and safely move new treatments to patients.

Collaboration ~ Design ~ Advocacy ~ Implementation ~ Impact

Contact Information:  Scott Riccio, Executive Director, (312) 420-3296
Website:  http://www.accelerateprogress.org

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