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CTL Sends FDA’s Sharfstein Letter Requesting Promised but Undelivered Expedited Review

March 18th, 2010 | Posted by Rory Kearney
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March 11, 2010

 

Dr. Sharfstein,

 

Can you please check with CBER and see why it is taking them so long to make a final decision on Dendreon’s Provenge.

 

The pending BLA is an amended BLA that was first submitted to the FDA in 2006. Following a March 2007 AC, in which the FDA hand picked experts overwhelmingly voted for approval, CBER decided to require additional proof of efficacy. That additional proof, as set forth in the SPA, was in fact obtained by Dendreon with results being announced in April 2009 (interim data was also positive and the IDMC also recommended approval in October 2008).

 

Now CBER has had all the new clinical data from the IMPACT trial as of July 2009 and all the CMC data since October 2009. Despite promises from CBER to the advocacy group CareToLive and others that they would review this treatment, intended for late stage prostate cancer, expeditiously, the treatment inexplicably remains unavailable.

 

This review is hardly being done expeditiously. FDA has now delayed this treatment from reaching patients for 3 years.

 

Please inquire/help.

 

Kerry M. Donahue, Esq.

Counsel for CareToLive

Dublin, Ohio

 

CTL Petition for reconsideration of May 2007 decision to issue CR filed in July 2007.

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This entry was posted on Thursday, March 18th, 2010 at 5:26 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.

One Response to “CTL Sends FDA’s Sharfstein Letter Requesting Promised but Undelivered Expedited Review”

  1. 1.
    john
    Says:

    March 25th, 2010 at 11:55 am

    Why would it take so long for FDA to approve since the data is not new, they looked at it once before. I’m afraid the FDA will reject Dendreon’s Provenge for late stage prostate cancer or there would have been approval by now what are they waiting for?

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WHATS GOING ON

This Is An Emergency!

We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.

The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
WE'LL BE BACK

These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.

The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.

These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.