
 


Internal Review Meeting - 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)
 
