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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Office Director Memo: Indication Statement - Provenge, April 29, 2010


From:  Celia M.Witten, Ph.D., M.D., Office Director FDA/CBER/OCTGT
To:  BLA/STN# 125197/0 Sipuleucel-T/Provenge® BLA file
Date:  April 29, 2010
Subject:  Office Director Memo:  Indication Statement

Sipuleucel-T (Provenge) is being licensed for the following indication:
PROVENGE is indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.  
This indication reflects the population studied.  The product is novel and it is not known if the study results are generalizable to a broader population with more advanced disease.  As noted in the clinical reviewers’ memo, pain is a prognostic factor for survival for castrate resistant (hormone refractory) patients and the amount of residual disease could affect the impact of this therapy since Sipuleucel-T is designed to work by an immunological effect.