Provenge and Meta-Analysis — Compare Avandia
In submitting Provenge vaccine for the treatment of advanced prostate cancer for fast-tracked FDA approval despite aborting one clinical trial due to failure to meet the primary endpoint, Dendreon relied on meta-analysis of combined data from two parts of a phase III study, D9901. In fact, after the trials failed to meet their primary endpoint, time to progression, they were analysed twice over. Dr. Eric Small presented meta-analyses of impact on overall survival and prostate cancer specific survival and Dr. Daniel Petrylak presented a further analysis or suvival focused on a subset of patients who, when they progressed on Provenge, took Taxotere.