	

Teleconference Memorandum - Weekly Update Telecon - Provenge, March 23, 2007




 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
 


TELECONFERENCE MEMORANDUM                                                   
Public Health Service
                                                                                 
             Food and Drug Administration
                                                                                 
             Center for Biologics Evaluation and Research
 
 

 

Date\Time: March 23, 2007

CBER Representatives: Keith Wonnacott, Stephanie Simek, Celia Witten, Boguang 
Zhen, Peter Bross, Kimberly Benton, Mark Davidson, Tom Finn, Ashok Batra, Lori 
Tull

Sponsor’s Representative: Elizabeth Smith, Mark Frohlich, Lianng Yuh, Connie 
Spooner, Nicole Provost, David Urdal

STN : 125197/0

Subject: Weekly update telecon

Discussion:

Advisory Committee

There was discussion regarding Dendreon’s slides for presentation to the 
advisory committee. Dendreon will submit their slides to Gail today.
  Cerebrovascular events for all randomized studies with treatment arms as 
  randomized (previously submitted; as reference)
  Cerebrovascular events for all randomized studies with treatment arms as 
  exposed to treatment (cross-over/salvage patients included in treatment arm 
  rather than placebo)
  Cerebrovascular events for all randomized studies with sipuleucel-T, salvage 
  and placebo broken out separately
  Observed time to cerebrovascular events from last infusion for all randomized 
  studies (data from D9902B/Study 3 now included)
  Overall survival by cumulative CD54 upregulation quartiles along with pure 
  placebo (Integrated Studies 1 & 2)
  Overall survival in salvage treated patients by CD54 upregulation quartiles 
  (Integrated Studies 1 & 2)

Product
  CBER stated that there was one issue with regard to Dendreon’s response to the 
  483. CBER requested to see and review the data for six lots in module b(4) 
  This data would be a major amendment to the BLA. Dendreon asked if CBER 
    would be willing to discuss other scenarios.

  Validation for 3 lots in the facility then submit a supplement for increased 
  capacity (b(4)), followed by an b(4)
  CBER responded that they would be willing to consider the limited capacity. 
  CBER would discuss this internally and then schedule another telecom with 
  Dendreon after the advisory committee to discuss the details. CBER would also 
  discuss the supplement pathway internally.
  Dendreon agreed.

OCTGT:IOD:Tull:3/26/07
(N:/IOD/Tull/125197/tcons/032307_weekly tcon.doc)
 
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