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Dendreon faces big hurdles on cancer vax

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Dendreon's announcement earlier this week that its cancer vaccine Provenge was a success in a Phase III trial elicited a euphoric response from investors, but a number of experts tell the Financial Times that the Seattle developer still faces some formidable obstacles before it can win an FDA approval.

Several industry insiders and Dr. C.K. Wang, an oncologist at the Cancer Institute of Dallas, say that Dendreon may well be asked to launch a confirmatory Phase III study to back up the new data. This is the first cancer vaccine that will be submitted for an FDA approval, putting Dendreon in unknown territory as far as regulators' appetite for risk.

"My guess is it will get back to ODAC [the Oncology Drugs Advisory Committee], and at that point, depending on who is on the ODAC committee, the reproducibility of the study will be called into question," one industry executive speculated.

Others speculate that Dendreon will also face some steep challenges before its manufacturing process for the new vaccine is approved. And the vaccine could face some heavy resistance from payers if the therapy delivers only a few months of added survival time.

- read the report in the Financial Times

Related Articles:
Dendreon says Provenge trial a success
Dendreon's Provenge is headed to the finish line
Dendreon shares soar on Provenge survival data
GVAX questions depress Dendreon shares
Next Provenge milestone: interim data
Optimistic Dendreon revs up second program

More stories about cancer vaccine   Provenge   Dendreon  

Comments

This is an attack story that has no merit. The manipulation of this stock is incredible and the shorts, real and naked, are desperate. After options expiration tomorrow expect this mudslinging to disappear.

Wang et al. did not do their research. This was the third Phase III trial of Provenge conducted by Dendreon and they are under a special protocol assessment essentially saying that if the results of this study are significant (and they are), then that is sufficient. The endpoints and statisical analyses were all prespecified and agreed to by the FDA. There will be no additional trial. But ignorance like that demonstrated above is what is providing a continuing buying opportunity, so I guess thanks.

I agree Dr. Wang et al. did not consider all the facts and in doing so lost perspective.
As a practicing MD myself, are not you, Dr. Wang presenting arguments counter to the ethics of being a physician - healers.
We are long past the acedemics and doctoral defences.
Is not promoting & prolonging the "Quality of Life" at all costs, empathy, and a deep spiritual respect for all those and their families who are suffering, systemic to your value system.
Most importantly, the time in which I am writing
to you, we are losing precious lives when there are options, such as Provenge.
In all due respect, I am expecting a response from you Dr. Wang.

Dr. Wang is not a qualified expert... Is that the best the short headge funds can do? Someone that is 3 years out of school, lol... Sounds like desperation for the shorts. Boy they had to dig long and hard to find him... My guess is that he is the brother or cousin of someone at a hedge fund that is short DNDN and is just trying to do his family member a favor...Unfortunatelty, its called corruption, I just wish the SEC was not a sleep at the wheel... A stock that's on the reg show list and this blatently untrue statement by Wang, should have flagged them...

As stated before, this drug was already recommended for approval before the last phase III clinical. It was on appeal from 2 of 17 committee members that caused the FDA to ask for additional phase III clinical. It has, apparently easily met the endpoint, even though the bar was set higher due to worries over statistical significance. Google Dendreon News for events leading to this point. Dr Wang is, as said before, uninformed.

RE: "My guess is it will get back to ODAC [the Oncology Drugs Advisory Committee], and at that point, depending on who is on the ODAC committee, the reproducibility of the study will be called into question," one industry executive speculated.

He is so uninformed he thinks Provenge went before ODAC. It went through the Biologics Advisory Committee. The oncology division was so outraged that they started the campaign to delay approval for two years. How many men had their lives shortened, Mr. "Industry Executive"?

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