Nov
22
2009
FDA To Rule on Provenge by May 2010
ByDendreon, the manufactures of sipuleucel-T (Provenge), announced that the U.S. Food and Drug Administration (FDA) has advised them that their updated application for approval has been completed and the company can expect a ruling of on or before May 1, 2010.
Provenge is the company’s investigational immunotherapeutic agent for the treatment of hormone-refractory prostate cancer, Read more about Provenge on this blog by searching for Provenge.
There is still time to add your name to Malecare’s petition to “MAKE PROSTATE CANCER A NATIONAL PRIORITY.” Go to prostatecancerpetition.org.
Joel T Nowak, MA, MSW
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This is potentially great news, since I seem to be running out of clinical trials as a result of various exclusion criteria. I have just been excluded from one trial and am in search of another.
Assuming that Provenge is approved by FDA, when might it be available? I assume that there will be some production ramp up time.
Tom,
As you assumed there will be a ramp up time for Provenge prior to its becoming easily available. The company (Dendreon) is in the process of building additional manufacturing plants to process the blood products. I know that the company is very aware of this issue and has spent time and money trying to figure out how best to manage this potential situation.
Joel