


Dendreon – Sipuleucel-T (Provenge) - BLA STN 125197 - Provenge, February 19, 
2010



 
Dendreon – sipuleucel-T (Provenge) - BLA STN 125197
 For the treatment of men with asymptomatic metastatic androgen independent 
prostate cancer
Internal Review Meeting, February 19, 2010

Attendees:
 Stephanie Simek
 Celia Witten
 Bindu George
 Peter Bross
 Chaohong Fan
 Wilson Bryan
 Robert Ball
 Faith Barash
 Robert Wise
 Craig Zinderman
 Bo Zhen
 Ghanshyam Gupta
 Lori Tull
 Patricia Holobaugh
 Bhanu Kannan

Discussion:  Postmarketing Requirement/Commitment

Discussion of process for developing a PMR
  safety risk or signal
  FDAAA criteria
  what study do we want
  can the study be conducted
  discuss with company
  negotiation of specifics

Signal for CVEs – a randomized double blind trial would be good, but not 
realistic, registry is a reasonable starting point.  AE reporting would not be 
sufficient to address a serious safety risk.

OBE will draft a letter by Monday

OCTGT:IOD:L. Tull:2/19/10
 (N:\IOD\Tull\125197\20100219_PMR Internal.doc)
 

 