Dendreon's Provenge Looks Likely to Be Approved in Mid-2010

Shares of Dendreon (DNDN) traded as much as five percent higher on Monday morning after the company announced that it has re-submitted its application for the regulatory approval of Provenge, a therapeutic prostate cancer vaccine that was called 'approvable' by the FDA in 2007. According to the press release, the company expects to hear an answer from the FDA at some point in mid-2010.

In 2007 the FDA - after deciding to wait until the ongoing IMPACT trial was completed before reconsidering the approval decision - indicated that they would approve Provenge if certain survivability points were realized; and those points were met in the Phase III trial, so things look good for the chances of a Provenge approval.

It's also important to note, however, that the FDA is still a federal regulatory agency consisting of a bunch of government employees, so nothing is a sure thing - especially in the world of cancer immunotherapy. That being said, I think that the chances of an ultimate Provenge approval are pretty good, considering recent events and past comments by the FDA.

If Provenge is once again pushed aside by the FDA, then I would expect to see a public outcry larger than the one that was ignited in 2007 that saw patients and investors alike join forces to lobby the agency for answers.

In March of that year an FDA advisory committee voted 13-4 that Provenge was effective and 17-0 that Provenge was safe. It was later discovered that two of the Doctors on the panel that voted against the effectiveness of the treatment - and who also subsequently lobbied heavily for the FDA to deny Provenge approval - were found to have previously undisclosed financial interests in companies in direct competition to Dendreon. If you need evidence of questionable ethics by those in positions of regulatory power, look no further than the Provenge story.

Broad market conditions will dictate the immediate future of the DNDN stock, in my opinion, but I expect the share price to approach the $35 level leading up to the FDA decision in mid-2010.

Additionally, if Provenge is finally granted approval, then it could lead to a nice rally in the cancer immunotherapy sector as a whole.

I continue to believe that immunotherapy is the 'next big thing' in cancer treatment, and a Provenge approval could be the event that brings the treatment to the mainstream.

As always, it's important to remember that the patients in need of the treatment receive the greatest benefits of these treatments; any financial gains enjoyed by investors is secondary in comparison.

Disclosure: No position.

Comments

[Reg Expert:]

FDA will approve as long as the company is honest and shows integrity in its analysis of data that forms the core part of its BLA. Unlike in the past, when the company tried to do the data manipulation by doing a retrospective analysis of subset of main trial population.

Nov 03 09:53 AM

[PaperGains:]

Approval looks extremely likely. Not sure why they didn't request Fast Track given the importance and that this is the second go round.

Nov 03 11:35 AM

[Wall Diver:]

Man, what an utterly clueless comment. What subset are you talking about? The previous pivotal trial was p=0.01 for survival over the entire intent to treat population. There was no subset submittal for the main dataset. DNDN was asked by the FDA in 1999, before the trial was initiated, to track the survival of every patient, even if it wasn't the primary endpoint. So how is that a retrospective analysis? There is no way you're a regulatory "expert," Mr. Clueless Newbie who's stuck in an untenable short position.

Nov 03 12:04 PM

[Teddie01:]

Very interesting...I have been following for quite some time and
contend that had this immunotherapy been for AIDS or Breast cancer,
it would have been approved after the first round.....

Nov 03 04:03 PM

[Reg Expert:]

Its amazing that people have short memory!
Previously, DNDN wanted to get approval based on small phase II trials with PFS as an endpoint (not overall survival).
When the briefing documents were released before the FDA's Advisory committe meeting last time, issues that Dendreon never publicly mentioned before came to light. Examples include the FDA's contention that Dendreon was improperly counting the number of prostate cancer survivors at 36 months in the d9902a study, and that some Cox multivariate regression analyses (sensitivity tests evaluating the efficacy of Provenge with a variety of variables included or excluded) were open to potential manipulation by Dendreon. Also, the overall survival results on which Dendreon likes to hang the Provenge efficacy results were pulled from a post hoc analysis of the small d9901 study and not from even a secondary endpoint of the clinical trial. As the FDA reviewer stated in the briefing document, "overall survival as an endpoint was NOT defined" in the study. Dendreon admitted this fact previously but it's worth mentioning again.
The current trial is a phase III larger trial with 500 patients and most importantly the endpoint is Overall survival per the FDA's agreement. Fooling the FDA should not be a goal of these companies. Otherwise, one would lose credibility!!
Check out what DNDN CEO Gold had to admit during 2007 Bio conference:
"As a field, as a whole, we've done non-controlled Phase II studies, and tried to translate that into Phase III studies - at Dendreon that's what we've done," Gold said. "What they're doing at GlobeImmune with the placebo-controlled Phase II study, and then taking it into Phase III I think is absolutely the way ... we need to go as an industry. Our Phase III studies were our first placebo-controlled studies, and we learned a lot from that."

Nov 03 09:39 PM

[Willard Can...:]

This article is right on target. The only exception I would take is the anticipated approval date. Since this drug will no doubt obtain a "fast tract" status and has been previously approved by a FDA panel it could be approved as early as late January 2010.

Nov 04 05:58 PM

[inhumane fda:]

Nice article.

Let me add something.

Dendreon filed the amended Biologics License Application (aBLA) with the FDA on October 30th. Dendreon had been rolling in the application and that was the date the full application was completed/submitted to the FDA. That means that the date by which the FDA must act is April 30, 2010. So while it is not incorrect to say that approval is expected by mid 2010 it will probably be much sooner.

The group CareToLive (CTL) has fought for expedited approval of Provenge so that men with late stage prostate cancer could begin receiving its benefits sooner. While the cold hearted FDA has turned their back on these men they did make one promise to the Citizens in their response to the CTL Petition and that was that they would expedite review of Provenge when the rest of the data was submitted by Dendreon.

Now remember, the application is an amended one that provides the additional data sought by the FDA per the Complete Response (CR) letter issued to Dendreon by the FDA in May 2007 (called Black Wednesday by Dr. Mark Thornton). The amended filing is not a new filing rather it amends the previous license request made by Dendreon in November 2006. Yes, that's no typo, I said 2006.

Note, that in October of 2008 the FDA received addditional data from an Independant Data Monitoring Compnay (IDMC) that was monitoring the Dendreon IMPACT trial. Those results were impressive and if the curves from the prior trials stayed consistent the final trial results were likley to meet the requirements set forth by the FDA in the CR. So the FDA knew again from the IDMC at the IMPACT interim peek that Provenge worked in 2008.

Point being is that it has been way too long! The FDA can approve this immunotherapy very quickly, even by December 25th 2009. It only has to want to do so. And why wouldn't it want to do so? This is after all a badly needed treatment for a late stage patient population that lacks good alternative treatments!

You are exactly right that approval day will be a big day for the patients and for the entire field of immunotherapy.....lets usher it in soon!

Nov 11 11:34 AM

[Blurtman:]

It is amazing that a failed gradient separation technology can be used to produce a dendritic cell vaccine that has efficacy. Look at the history underlying DNDN's manufacturing technology, it is a dinosaur technology that did not work for hematopoietic stem cell enrichment. Something doesn't add up here.

Nov 16 05:02 PM