November 23, 2009

SENT BY FACSIMILE AND U.S. MAIL

Citizen Petition -2007-P-168

Karen Midthun, MD
Acting Director of CBER
Food and Drug Administration
1401 Rockville Pike
200N
Rockville, MD 20852

Dear Karen Midthun, MD ,

I am representing and speaking for an advocacy group by the name of CareToLive. The group CareToLive filed a Citizen Petition with the CBER division of the FDA on July 26, 2007. That Petition asked for a reconsideration of the May 2007 denial of a license for distribution of Provenge, made by Dendreon Corporation. Provenge is a treatment for late stage prostate cancer, which is a patient class without appealing treatment options.

While your office denied that petition in early 2009 you did indicate that when your office did obtain the remaining data requested from Dendreon (the results of the IMPACT trial), that, as stated several times in your Petition response, CBER would expeditiously review that data.

The last line of the CBER response said:
“We look forward to receiving Dendreon’s amendment to its existing BLA so that we may review this information expeditiously.”

While we were disappointed that CBER did not end the IMPACT trial based on the interim data provided by the Independent Data Monitoring Company (IDMC) that CBER was presented with in mid 2008, as that was clearly additional confirmation that Provenge was safe and effective, so that the patients who are in great need could have started receiving Provenge much sooner, we remain hopeful of expeditious review now that the trial was completed and you have all the data.

Now, 2 ½ years after the original AC panel of experts voted to approve Provenge you have been provided a response by Dendreon to your then issued CR letter. You now have all the new data requested as of October 30, 2009 which was the day Dendreon completed its rolling aBLA submission.

We are writing you this letter to remind you of the promises made in your response to the CareToLive Citizen Petition to review the data expeditiously. Please devote whatever resources you can to this evaluation so that it can be timely completed. Remember that this is no ordinary application; rather it is an application for approval of a treatment for end stage prostate cancer for which viable treatment options do not exist.

We at CareToLive get e-mails and letters from patients and their families every week who desperately want Provenge for themselves or their loved ones. Some of the stories we hear are heartbreaking. Having Provenge approved by Christmas of 2009 would provide much hope and joy to these patients and their families at a time of year when joy is needed. Recently we lost one of our advocates, Bruce Tower to late stage prostate cancer. Mr. Tower got a placebo in the IMPACT trial. We understand that at the beginning not everyone that wants Provenge will be able to get it, but we have to start somewhere. Approval by Christmas would be an act worthy of much praise and many advocates including CareToLive will praise such effort as we understand you would need to work diligently for such an extraordinary and very humane effort to occur.

If you think the timetable for approval of Provenge by Christmas is impossible, then please explain why it is impossible so that we can try to understand. While I know you are extremely busy folks there, this is a treatment for which the original BLA was filed (and voted to be approved by experts soon thereafter) in November 2006.

If expeditious review is something that you no longer think your division is capable of, then we would like to meet with you to discuss it. We will come to Rockville for such a meeting (or anywhere else you like). We would like the meeting to be held one or two weeks after Christmas, if you are available. We would like to bring several board members from CareToLive as well as about 5 other prostate cancer advocates including Thomas Farrington (PHEN).

If approval can be completed expeditiously there is probably little reason for the post Christmas meeting to occur. If that approval is impossible within that time and you do not estimate approval in the days or week thereafter then these advocates would very much like to meet with you so as to discuss the issues involved with the inability to move expeditiously as promised in your Citizen Petition response, on the amended BLA for Provenge.

Thank you very much for your time and consideration of this matter.

Sincerely,

Kerry Donahue

Popularity: 10%

Tags: Care To Live, CareToLive, CBER, Dendreon, FDA, Karen Midthun, Kerry Donahue, provenge

This entry was posted on Monday, November 23rd, 2009 at 11:02 am and is filed under The Cause, The Dysfunctional FDA. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.