
Provenge (sipuleucel-T) BLA STN# 125197 Review Memorandum, Provenge, April 27, 
2010


 
Food and Drug Administration
 Center for Biologics Evaluation and Research
 Office of Compliance and Biologics Quality
 Division of Case Management
 Advertising and Promotional Labeling Branch

REVIEW MEMORANDUM

Date: April 27, 2010

To:
 Elizabeth C. Smith
 Vice President of Regulatory Affairs
 Dendreon Corporation

From:
 Catherine Miller, MT(ASCP)
 Consumer Safety Officer
 Advertising and Promotional Labeling Branch (APLB)

Through:
 Jean Makie, MS, RD
 Acting Branch Chief, APLB

Product:
Provenge (sipuleucel-T)
BLA STN# 125197


The Advertising and Promotional Labeling Branch, in consultation with the Office 
of Cellular, Tissue and Gene Therapies, has reviewed the draft press release 
submitted by Dendreon on April 22, 2010. We have the following comments.

First paragraph under “Clinical trial Results Supporting FDA Approval” on page 1
  The claim “This study demonstrated a statistically significant improvement in 
  overall survival and showed that treatment with Provenge improved the 3-year 
  survival rate by 38 percent compared to placebo (31.7 percent versus 23.0 
  percent)” misleadingly overstates the efficacy of Provenge. This analysis was 
  not pre-specified and is an estimate from the Kaplan-Meier curve. The 3-year 
  survival analysis is based on very few patients with a huge variation for the 
  estimate. The actual analysis of the overall survival was done at about 20 
  months. Please delete this claim.
  The claim “Results from the similarly designed Study D9901 in asymptomatic 
  metastatic CRPC also demonstrated a significant survival advantage” is 
  misleading because it lacks sufficient contextual information for “significant 
  survival advantage.” We recommend that you revise the claim to “Results from 
  the similarly designed Study D9901 in asymptomatic metastatic CRPC also 
  demonstrated a survival advantage of similar clinical magnitude as D9902B” or 
  similar wording.

First paragraph under “About Autologous Cellular Immunotherapy” on page 2
  The claim “Provenge is classified by the FDA as an autologous cellular 
  immunotherapy, an active cellular immunotherapy designed to stimulate a T-cell 
  response to cancer cells” is misleading because the word “active” modifies the 
  classification, which is not appropriate. We suggest the following language 
  “Provenge is classified by the FDA as an autologous cellular immunotherapy. It 
  is designed to be an active cellular immunotherapy that stimulates an immune 
  response to prostate cancer cells.”

If you have any questions regarding this review please contact Catherine Miller, 
Consumer Safety Officer at 301-827-3028.
 

