After three years of anticipation, disappointment and controversy, the FDA has approved the Provenge prostate cancer vaccine, which threatens to revolutionize treatment. The agency endorsement comes earlier than expected, since the PDUFA date was actually May 1.
Despite the rollercoaster ride this vaccine has taken, most anaylsts expected FDA approval would be granted and, in fact, the stock has been climbing in anticipation in recent months. Trading was briefly halted today, but has since resumed and Dendreon shares have jumped about 15 percent.
Now that months of speculation over the fate of the vaccine has ended, the issues going forward will be whether Dendreon can deliver on its promise of essentially customizing a vaccine for each prostate cancer patient and the extent to which insurance coverage will suffice.
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3 Comments
Why does it happen? Because it happens. Roll the bones!
Get busy!
MB
FDA should have mandated the initiation of outcomes studies (all cause morbidity, mortality, and survival) from day 1 as an absolute requirement for approval. There are literally hundreds of "jabs" (inoculations) in the pipeline. Of course, they (the jabs) will all always be discretionary for the public...right?
American Cancer Society's Dr. Len Lichtenfeld has some interesting perspectives about the Provenge vaccine cancer drug. The point about it being a vaccine and not so much a targeted drug. The treatment will only be available for men whose disease has progressed despite hormone treatments, and the men have to either be free of symptoms or have only minimal symptoms at the time of treatment.
He fears that this breakthrough will be used to give false hope to last-stage cancer patients and seems less than hopeful that this is a scientifc breakthrough that will lead to further breakthroughs. He believes Medicare will have no choice but covering it, as most patients will be on Medicare, which will be a major burden for the Medicare budget.
http://www.cancer.org/aspx/blog/Comments.aspx?id=353