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Vaccines, Blood & Biologics

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


Date: April 27, 2010

Elizabeth C. Smith
Vice President of Regulatory Affairs
Dendreon Corporation

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

Jean Makie, MS, RD
Acting Branch Chief, APLB

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.

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