Wall Diver

The Short Case on Dendreon Corporation

"If the TTP of If the TTP of patients with Gleason scores (GS) of 6 and 7 or less were so important, one would think that these patients would have progressed slower than those with Gleason scores of 8 to 10. However, the median TTP for the GS 7 or less patients was 9.0 weeks, while the median TTP for the entire placebo arm was 10.0 weeks. This just goes to illustrate the fact that the FDA considers TTP a not so reliable surrogate endpoint, judging from the ODAC meeting a couple years ago on surrogate endpoints for advanced prostate cancer trials. Survival is the true gold standard.