Dendreon announced today that it expects to have interim data for Provenge for prostate cancer in October 2008. Now the waiting for Provenge game has a clearer time frame attached to it.
If you have followed the Dendreon Provenge story (See my Dendreon (DNDN) page), you know that Phase III trials of Provenge for treating metastatic prostate cancer had some interesting results. An FDA committee recommended that Provenge be approved for treatment, but the final (so far) decision was to ask for more data. There were accusations that the committee members who nixed Provenge had relationships with competitors. Prostate cancer victims who know that Provenge, which is an immune therapy, is safe and sometimes effective are angry about the FDA decision.
The FDA and Dendreon have agreed in advance what the threshold must be in the current trial for the FDA to grant approval for allowing doctors to treat patients. However, statistics are involved. If Provenge has (to some degree) effective, the more patients who try it, the more a positive outcome is probably reality based, rather than just a random statistical fluctuation.
Dendreon thinks the earlier statistics will hold up when a larger number of patients are tested. In October an independent committee will look at the data from the current trial. If the data show a sufficient degree of benefit to patients, this interim analysis will be taken to the FDA for approval. If the data is good but not statistically strong enough, the trial will continue. If the data is so poor that even improved outcomes in the next leg can't raise the benefits to a statistically significant level, then probably the trial will be stopped, and certainly Dendreon investors should be informed.
The sad thing, if Provenge is approved, is that a large number of men who would have benefited from the therapy will have died in the meantime, or will have seen their cancers progress to the point where Provenge is no longer effective. Including those who were given placebos in the current double-blind trials.
Provenge, if it works, would be proof of concept to a whole new biotechnology. If money flows in after approval, expect Dendreon to conduct tests on a wide variety of cancer types (every cancer type is different, so each requires a different chemical target to be verified for the technology to work.)