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Thomas A. Farrington Article

THE ROAD TOWARDS PROVENGE APPROVAL IN 2008

By: Thomas A. Farrington
President and Founder
PHEN

During the first two weeks of 2008 the US Food and Drug Administration’s (FDA’s) delayed approval of Provenge, the first ever prostate cancer therapeutic immunotherapy vaccine, continues to be a headline issue as it was for most of 2007. In fact the issue seems to be gaining momentum with a focus on reasons “why” the treatment was not approved by the FDA after being recommended for approval by an FDA advisory committee in March 2007.

“In the coming weeks, it looks increasingly likely that the US Congress will launch an investigation into the circumstances behind the FDA’s decision last May to delay approval of Provenge;” states the editorial in the January issue of “Nature Biotechnology.”

Having had the opportunity to present before the FDA advisory committee convened to consider Provenge approval last March, I along with all the other survivors and advocates who presented, urged this committee to recommend approval based upon an unmet treatment need and the scientific data from the Provenge clinical trials. We were elated when the committee voted 17 to 0 that Provenge was safe and 13 to 4 that it met the FDA’s efficacy standards - an overwhelming recommendation to the FDA for approval.

Finally, we thought, there would be a treatment for terminally-ill prostate cancer patients without the severe side effects brought on by chemotherapy – the only existing treatment for late stage disease. Also, Provenge would provide a treatment for those thousands of terminally–ill prostate cancer patients unable to endure toxic chemotherapy, those like my father who died from this disease with no available treatment option. In addition we envisioned the potential for Provenge to open doors for a whole new class of immunotherapy treatments that could possibly be effective at earlier disease stages while maintaining a better quality of life for patients than today’s treatments. All of these hopes were put on hold when the FDA rejected the recommendation of its own advisory committee and directed Dendreon, the company behind Provenge, to continue with its clinical trials and come back with more data on Provenge’s efficacy.

The outcry from the patient community against the FDA’s decision has been strong and persistent, keeping the Provenge issue alive and leading to the current state where the US Congress is “likely” to investigate. For the millions of prostate cancer survivors this issue is about preserving lives and the quality of our lives. From various accounts it now appears that our interests and needs may not have been the priority with the FDA’s decision making process. The “Nature Biotechnology” editorial cites “irregularities” consisting of financial and other conflicts of interests on the part of some of those involved in shaping the FDA’s decision. It is my understanding that these irregularities would be the subject of a congressional investigation. I would hope, and believe, most everyone will applaud and support all actions to expose and punish individuals involved in an inhumane conspiracy to deny a safe and effective treatment from suffering and dying men.

Moving forward we must also keep our eyes on the prize – Approval of a breakthrough and landmark prostate cancer treatment. During 2008 Dendreon is scheduled to provide the FDA with new interim data from its on-going Provenge clinical trials. With the events of the past year as lessons learned that should guide us, we must demand that the FDA’s evaluation of this data, and complete decision making process, is expedited and totally transparent to the public. The FDA should clearly outline the process that will be used in determining whether the interim data supports Provenge approval. The agency should also outline how approval can be expedited if the data meets approval conditions, and it should commit to this expedited process. And again, every single FDA action taken in this process should be open and transparent to the public.

The hopes and excitement of prostate cancer survivors exhibited across this country following the FDA advisory committee’s positive recommendation in March 2007 are still alive, and the unmet treatment needs still exist. Millions of prostate cancer survivors sit on the time bomb of a cancer recurrence knowing that with treatments available today this will mean a compromised quality of life, and in many cases death. For African American families, where men experience a prostate cancer death rate 2.5 times that of other men, there is added urgency for new treatments to relieve a widespread and frightening epidemic of suffering. All survivors realized a setback with the FDA’s decision to delay approval of Provenge in 2007, but we must and will persevere until we get a fair assessment whether Provenge is an answer to our needs – The FDA’s own advisory committee thought it was. We see no other treatment options on the immediate horizon with the potential impact of Provenge, so we have no choice but to see this single option fully exhausted.

For men in the US, prostate cancer is the leading cause of cancer and the second leading cause of cancer deaths. Prostate cancer patients are in desperate need for new treatments that will save lives and the quality of lives. A transparent, fair and expedited FDA review for Provenge is a critically important step in helping meet this need, and restoring some confidence in an FDA process that is suspected of serious “irregularities.” The US Congress needs to also insure that this critical step is taken.

http://www.prostatehealthed.org/phen_Detail.php?News=673