Biologics License Application 125197 Sipuleucel-T (APC8015)
Agenda for clinical/stats initial T’con with BLA applicant Dendreon 11/06/09
Administrative, introduction of review team
Lori Tull – RPM
Peter Bross – Clinical Team Leader
Bindu George – Primary Efficacy
Chaohong Fan – Primary Safety
Boguang Zhen – Primary Stats
Information request to sponsor: (we don’t expect to have this completed overnight however if Dendreon needs clarification regarding these requests please feel free to ask at the t’con tomorrow. We can schedule a follow-up t’con to discuss the responses).
- Please provide a data listing of Halabi scores (expected survivals) at the time of progression for those subjects who were documented to progress. For subjects who received APC8015F please also provide scores at the time of progression following infusion of the frozen product. If the data have been submitted, please provide the variable name and dataset.
- Please conduct exploratory sensitivity analyses comparing overall Kaplan Meyer survivals between the two treatment arms: subjects who received subsequent Docetaxel treatment, and subjects who did not receive subsequent Docetaxel treatment (four subgroups).
- Please repeat the above analyses for subjects on both arms who received salvage Docetaxel treatment at or reasonably close to the approved regimen of 75/M2 Q3 Wks, and subjects who did not receive salvage Docetaxel treatment at or reasonably close to the approved regimen of 75/M2 Q3 Wks (four subgroups).
- Also please provide an analysis of median Halabi scores at time of progression for the subgroups described above.
- Please provide a data listing (SAS file) of those patients who were documented to have received salvage Docetaxel treatment at or reasonably close to the approved regimen of 75/M2 Q3 Wks.
- Please provide an analysis of the T cell responses (IFN-γ and Proliferation) noting any correlations between the responses and survival data.
- Please provide any preliminary data that is available regarding T cell responses noted in P07-1 trial.