How many patients actually want to take Provenge, and how many doctors want to prescribe it?
Provenge has failed in both of its main studies--but it seems to help patients live longer.
Dendreon needs to convince the Street that Provenge is on the road to blockbuster status.
FORBES: Good News For Dendreon As Manufacturing Site Approved
Approving Provenge might make it difficult to find out whether Provenge's benefits are real.
In the light of this more rigorous analysis, the handling of Provenge looks pretty typical.
But the special circumstances of the Provenge case make this decision difficult to predict.
Ethical considerations might require switching those patients on placebo to the drug, if Provenge is approved.
The panel did weigh those risks, and it still recommended Provenge by a 13-4 vote.
Colleagues convinced Penson to give Provenge a try in clinical trials, and he was impressed.
Provenge was once widely expected to be a blockbuster, but demand has never panned out.
FORBES: The Key Question For Dendreon: Is There Demand For Provenge?
Right now, Provenge as a product does not seem like much of a gem.
FORBES: The Key Question For Dendreon: Is There Demand For Provenge?
The good news for Dendreon investors is that Provenge should come through this ordeal relatively unscathed.
The results, a planned peek at an ongoing 500-patient study meant to prove Provenge's worth, were promising.
Before the panel decision came in, he said he would be "shocked" if the FDA approved Provenge.
Another worry is that the benefit of Provenge might be real but less robust than it appears.
But prominent cancer researchers have said the clinical trials Dendreon conducted failed to prove Provenge helps patients.
The panel voted 13 to 4 that Provenge should be approved, causing Dendreon shares to quadruple.
Dendreon's (nasdaq: DNDN - news - people ) Provenge is a so-called cancer vaccine.
First, paying for Provenge does present some unique challenges, because it is very different from other treatments.
Abiraterone is dramatically different in several ways from another high-profile prostate cancer drug, Provenge, from Dendreon of Seattle.
If it does, it could eventually be promoted by the same sales force Dendreon is building for Provenge.
Here are five key numbers that will help determine how fast Provenge, the first therapeutic cancer vaccine, sells.
And the review gives Medicare plenty of ammunition not to pay for off-label, or unapproved, uses of Provenge.
Provenge is potentially revolutionary because it aims to teach the body's own immune system to attack tumor cells.
In cancer, we did better: Avastin, from Roche, and Provenge, from Dendreon, were among our picks.
Its lead drug candidate will remain Provenge, a vaccine to treat prostate cancer.
Dendreon is already conducting a 500-patient study that will give a much clearer answer as to whether Provenge works.
The data has convinced some who were skeptical that Provenge may have merit.
This 500-patient study is comparing Provenge to a placebo version of the treatments.
His office is completely removed from the one that convened the Provenge panel.
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