Yesterday, Dendreon Corp (DNDN) announced that the FDA has agreed to allow them to amend the trial design of its Provenge cancer vaccine. The change in the design will accelerate the expected timing of the final study results by about one year.
According to Dendreon, the interim results of the impact study are still expected in the second half of 2008. However, final results of the study are now expected in the second half of 2009 rather than 2010.
The U.S. Food and Drug Administration reconfirmed that the agency will accept positive interim or final survival data from the ongoing trial when they re-review the approval application.
In May 2007, the FDA issued an “approvable letter” for the drug, but they asked for additional data. The Impact trial will hopefully satisfy the FDA so that the drug can finally be approved.
Search my blog for a complete background about Provenge.
Joel T Nowak MA, MSW