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Vaccines, Blood & Biologics

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

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

  1. safety risk or signal
  2. FDAAA criteria
  3. what study do we want
  4. can the study be conducted
  5. discuss with company
  6. 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)

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