Dendreon states that Provenge improves survival

According to a statement by Dendreon on a teleconference early this morning and also in a media release on the company web site, the investigational agent sipleucel-T (Provenge) has met the prespecified end-point for extending survival of patients with hormone-refractory prostate cancer in the Phase III IMPACT trial compared to placebo.

The “New” Prostate Cancer InfoLink wishes to emphasize that Dendreon has released absolutely no data in confirmation of the above statement. They will present these data at the upcoming Ameridcan Urological Association annual meeting in Chicago, on April 28.

Advocates for the early approval of sipleucel-T are already suggesting that patients should put pressure on the US Food and Drug Administration (FDA) to approve sipleucel-T immediately. The “New” Prostate Cancer InfoLink disagrees profoundly with this position. As yet we haven’t seen the results of this trial, and these new data have not been submitted to the FDA for regulatory review.

8 Responses

  1. Finally, a sensible position. I am wondering why all the articles posted in the PC forums are company press releases or articles by stock market watchers. I am genuinely interested in learning more about Provenge, and so I will have to do a Google and see if I can come up with something written by a medical professional.

    Is it standard for companies to be so secretive about specific outcomes?

  2. I listened to the call this morning and found that they really didn’t provide any information. I have no evidence of this, but a little voice inside my head was telling me they were having the press conference to pump the stock. I sold all my shares as it rose to $20!!!

    As someone who will personally benefit from good news on this treatment, I remain highly skeptical.

  3. Leah:

    Small biotech companies like Dendreon are caught between the disclosure requirements of the Securities and Exchange Commission, the communication limits of the Food and Drug Administration about the effectiveness and safety of unapproved drugs, and the customary scientific requirements to only present scientific data within scientific forums.

    Thus, today was what I expected. They said they have reason to believe that is effective (which they had to do to meet the SEC disclosure requirements) but they said nothing more because the FDA says that they can only say what they need to say to meet SEC requirements, and the medical science communities want to hear the full details from one of the principal investigators (presumably Eric Small, MD) at the AUA in two weeks.

    Dendreon is not being secretive. It is being careful about exactly who says what and in what forum. My personal view is that they shouldn’t have had the teleconference this morning. The media release would have had exactly the same effect, and David’s stock might have gone even higher! I am pretty sure that the analysts on the call this morning were unhappy about having to get on a call to be told nothing that wasn’t in the media release.

  4. Mike, Your clear bias against Provenge is showing. This treatment should have been approved a long ago. It is a travesty that it remains unavailable.

    Dendreon didn’t say that Provenge seems to be effective.

    They said it clearly and unambiguously met the primary endpoints set forth in their SPA. This is their third phase 3 trial which confirms the results of the previous trials.

    Here are some of Dr. Gold’s words concerning the results: “met its prespecified end points,” “confirms results of previous studies,” “data met criteria and specifications of Biologics License Application,” “results were robust,” “results were unambiguous and held up to multiple sensitivity analysis,” “a clear hit on statistical significance”.

    In the course of our medical history revolutionary change has been and apparently will always be attempted to be slowed/halted by some.

    By the way the patients will continue to be followed over the years and not stopped at 36 months as in previous trials so you can expect even greater demonstration of efficacy over time. Also there are two ongoing trial sites that are also testing, via ongoing trials, varying degrees of dosage and timing of treatments so as to ultimately determine the best application of this new therapy.

    The data is reported to be supportive of the previous trials that one FDA Advisory Committee panel already voted in favor of over 2 years ago. The FDA needs to act to accelerate availability of the treatment for the AIPC patients.

    This additional data should not even have had to be necessary but you will have it in 2 weeks none the less. Let’s try to work together to get it to the patients long before 2010.

    Even the long time primary opponents/antagonists of Provenge indicated that if IMPACT confirmed evidence of efficacy Provenge seen previously, it should be approved.

  5. Dear Kerry:

    I am not in the slightest bit “biased against Provenge.” Provenge is a drug. It has either met the endpoints or not. I very much hope that it really has.

    I will very freely admit that, based on historic experience, I am suspicious of the way in which Dendreon and its executive management has presented data about Provenge over the past nearly 10 years. The executive management has regularly indicated a far greater interest in the stock price of the company than the actual need to demonstrate the effectiveness and safety of its products. And I am saddened to see this happening again. Yesterday’s conference call was simply not necessary.

    Finally, if you want to see the FDA approve Provenge prior to 2010, the answer is not in my or your hands. It is in Dendreon’s hands. The sooner they submit the new data to the FDA, the better the chance they have of getting the product approved. I am not your problem, however easy it may be to criticize me for stating facts that people deserve to know.

  6. That’s fair enough.

    However, Dendreon has been trying to demonstrate the safety and efficacy of Provenge for 10 years at a cost of over 700 million dollars. It has been no easy feat to keep the company economically viable to accomplish that. In fact their continued order to provide more evidence when there was a lot of evidence already, took funding away from their development of other immmunotherapies such as Nuevenge for breast cancer which has shown promise.

    We would know more about Provenge right now it the patients would have had access over the last 2 years.

    Remember at the Provenge Advisory Committee Dendreon said it was committed to completing the IMPACT study whether the FDA granted approval in 2007 or not. In fact, that was one of the reasons often given by FDA supporters that they should wait until IMPACT is completed.

    IMPACT has been going on since 2003. As you know immunotherapies are not chemotherapy; they take time to work and thus to assess.

    Dendreon financed this effort privately without NCI or DOD or PCF or other funding help. Again no easy task.

    I am willing to take the lead to try and get data from Dendreon to the FDA sooner but I also think that we have to see a commitment from FDA to be open to accelerating the approval process. If the FDA will open it eyes and ears, we should speak to them together.

    One way the FDA could communicate this new openness to patient advocate input is to grant the Citizen Petition which means they are agreeing to reconsider the 2007 denial of a license. This would be a giant step forward. The FDA has all the earlier trial data (sufficient itself) and some interim data from October 2008. Does Dendreon’s current mistrust of the FDA lengthen their time line for submission … maybe!

    A little give and take could go a long way. One short statement from Jesse Goodman at the FDA saying “we grant the Citizen Petition” would speed the licensing process immensely.

    I hope for your endorsement come April 28th! I also hope that you will then help us in the effort to accelerate availability to patients.

  7. As a member of the Alliance for a Stronger FDA, I am on record for greater transparency with regard to FDA decision processes. If the data presented on April 28th looks and smells good, I shall certainly be encouraging Dendreon to submit the data in a timely manner and the FDA to review these data as rapidly as possible. You should consider the possibility that the new FDA Commissioner is likely to be looking for a way to “make her mark” firmly and quickly with consumers. Provenge may offer her that opportunity.

    One other small point. Dendreon’s decision to “go it alone” without any form of outside financial support is not a good excuse for not getting the drug to market. In my view it reflects the company’s desire to retain all the rights to the drug in the hope of significant profits, and if they succeed, and the product is wildly successful, then I am sure Dendreon’s stockholders will be very happy rabbits.

  8. Now we are talking!!!

    Talk to you on the 28th :)

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