Dendreon files revised BLA for Provenge

Earlier this year, Dendreon stated that the company expected to file a revised Biologics License Application (BLA) for sipuleucel-T (Provenge) by mid-November. The company  reported today that filing of the revised BLA is now complete.

The filing of the revised BLA ahead of schedule (if only by a couple of weeks) is potentially good news for the patients who have been waiting for the chance of treatment with Provenge. However, they will still have to wait while the US Food and Drug Administration (FDA) studies the completed BLA and comes to its decisions about the application to market the product.

Data presented at the annual meeting of the American Urological Association last April clearly indicated that sipuleucel-T extended the median survival of men with hormone refractory prostate cancer by 4+ months compared to a placebo, and with relatively minor side effects. However, the data provided to the FDA will be a great deal more detailed, and we will all need to be patient while the FDA assesses these new data.

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