Yesterday, the Dendreon Corporation announced some data presentations that were to take place at the 2011 Genitourinary Cancers Symposium annual meeting in Orlando, Florida. In one of the presentations, there were data that showed subsequent treatment with APC8015F (frozen Provenge called Frovenge) may have prolonged survival of the control arm in Phase 3 Sipuleucel-T Studies.

Dendreon’s press release can be read here:

http://finance.yahoo.com/news/Dendreon-Announces-prnews-2424909414.html?x=0&.v=1

When Dendreon performed their trials, all the men gave blood samples and had that blood treated with Provenge. In the placebo control group they did not get infused with that treated blood, rather it was frozen to preserve it. It was called Frovenge, a less potent form of Provenge.

For humane reasons, upon progression of deteriorating patients in the placebo arm, Frovenge was administered, now competing against itself, as mandated by the FDA for the placebo group in the Provenge trial.

Now we are seeing results which show that Frovenge worked. It extended survival. We really do not know how good this treatment is, but so far it is performing beyond our expectations. Thinking how this groundbreaking medical science is planned for other cancers is truly exciting.

Here is another article commenting on this new data:

http://seekingalpha.com/article/253708-good-news-for-dendreon-s-provenge?source=yahoo

Popularity: 10%

The Department of Justice (DOJ) submitted a brief on behalf of the FDA, in opposition to CTL’s Motion to conduct discovery (see second link)

You can read their entire brief here >> fdafoiamotion-memocontra-0613.pdf

* * * * *

CareToLive does not agree, and our attorney, Kerry Donahue, will be filing a response.

* * * * *

CareToLive MOTION FOR LEAVE TO CONDUCT/COMPLETE DISCOVERY UNDER CIVIL RULE 56(f)
AND PARTIAL MEMORANDUM CONTRA TO DEFENDANT FDA’S MOTION FOR SUMMARY JUDGMENT

Link to Motion >> ctlfoiaresponse6-06-09c.pdf

 * * * * *

Here are the FOIA Documents we received from CDER, requested by us almost 2 years ago in August of 2007, requesting FDA correspondence with Richard Pazdur concerning the Provenge delay of approval.

Freedom of Information reveals Dr. Pazdur searched both his paper and computer files and could not locate any documents responsive to plaintiff’s request.

Received 5/18/2009 Freedom of Information Act (FOIA) documents

Declaration of Richard Pazdur >> ctlpoaz29exbd-5.pdf

Defendant FDA’s Motion for Summary Judgment >> ctlsj29-1a.pdf

Declaration of Fredrick J. Sadler >> exba.pdf

Declaration of Nancy B. Sager >> ctlexhibitc3.pdf

Declaration of Beth Brockner-Ryan >> ctlryanexhibitb.pdf

From FDA, affidavit from Dr. Pazdur (above):
See id. at ¶ 6. Dr. Pazdur recalls receiving both hard
copies and electronic copies of the letters from Drs. Hussain and Scher in April 2007. See id. at  ¶ 7. However, as these letters related to a specific regulatory application conducted by a  different FDA Center (CBER), did not fall under his direct regulatory supervision, and did not  require a response from him, Dr. Pazdur shredded the hard copies of these letters and deleted any  electronic copies. See id. The documents were shredded and deleted within a month of receipt.  See id. In fact, Dr. Pazdur does not keep personal copies of any regulatory communications.  See id. at ¶ 8. Official copies of regulatory correspondence are kept in the official regulatory  document room of the specific center assigned to an application. Id.  Contrary to plaintiff’s suspicions, Dr. Pazdur never disclosed Dr. Scher’s or Dr.  Hussain’s letters to “any individuals outside of the FDA, or any media outlet, including a  publication called ‘The Cancer Letter.’” See id. at ¶ 9. In addition, he did not write any portion  of the letters that Drs. Scher, Hussain, or Fleming sent to the FDA. See id. at ¶ 10. He also never received a copy of a letter from Dr. Thomas Fleming to the FDA regarding Provenge. See id. at ¶ 11.

* * * * *

It took the FDA 2 years to deny the CareToLive Citizen’s Petition.

FDA’s Response to CareToLIve Citizens’ Petition >>  fda-response-to-citizens-petition.pdf

Popularity: 12%

The FDA blew a golden opportunity.

It took them 2 years of foot dragging to reach their decision on our CareToLive Citizens’ Petition.

They DENIED it!

The only redeeming factor in their pages of excuses, is that the FDA stated 3 times that they will process the amended Dendreon BLA expeditiously.

We at CTL feel the FDA lacks the compassion and the scientific ability to evaluate our Petition.

With the stellar Provenge survival data recently exhibited, we believe the FDA should have immediately reconsidered their death rattle.

Apr 28, 2009
Data Presented at AUA Demonstrate PROVENGE Significantly Prolongs Survival for Men with Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study (LINK)

The dysfunctional, omnipotent FDA has spoken loudly and clearly to the men with late stage prostate cancer who are out of options.

You can’t have a safe and effective immunotherapy yet.

Go home and die!

You can read the FDA’s response here >> fda-response-to-citizens-petition.pdf

Here are some of our thoughts on the FDA response. We welcome your comments.

Before addressing the specific requests in your petition, we first want to make it clear that we share your concern for men suffering from advanced prostate cancer.

Too many men continue dying a painful death while the FDA continues to stonewall the approval of Provenge by not addressing the deception that took place during the Provenge approval process.

We are committed to expeditiously reviewing the new information as soon as it is submitted.

This was the only good thing we read in their response.

PLEASE HURRY.

THIS IS AN EMERGENCY!

FDA shares the goal of approving new products, such as Provenge, as soon as they are shown to be safe and effective.

Provenge has shown all along that it is safe and effective. The Advisory Committee questions are regulatory questions.

Is it safe?

Is there substantial evidence of efficacy?

The panel voted overwhelmingly that it is safe and effective.

The FDA response tried to gloss over the conspiracy and conflict-of-interest issues, simply denying them without offering any evidence.

The agency lied when it said Provenge didn’t slow progression in either 9901 or 9902A. The correct terminology would have been “did not slow progression with statistical significance.”

We think that 11.7 weeks vs. 10.0 weeks in the 9901 trial is evidence of slowed progression.

A p value of 0.052 (Journal of Clinical Oncology number) or 0.085 (FDA number) should not be taken lightly, even if it did barely miss statistical significance.

Combine that with the survival p value of 0.01, and that’s pretty convincing evidence that 9901 was a successful trial.

It is a lie that Provenge did not slow progression in 9901, and it is a lie that there is no positive correlation between progression (91.5-94.8%) and survival (99.0%). The FDA’s progression argument is a LIE.

FDA has a long history of permitting access to investigational drugs to treat serious and immediately life-threatening diseases without adequate available therapies. Individuals can obtain access by enrolling in on-going clinical investigations of such products, including any existing expanded access protocols.

Continue Reading FDA LIES & DENIES — CARE TO LIVE CRIES »

Popularity: 12%