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Vaccines, Blood & Biologics

FW: Dendreon Provenge CDER BLA Labeling Consult - Provenge, February 24, 2010

From:Tull, Lori
To:Jones, Karen;
cc:OC Combination Products;
Subject:FW: Dendreon Provenge CDER BLA labeling consult
Date:Wednesday, February 24, 2010 1:50:16 PM
Attachments:125197 label.pdf
125197 Provenge draft-label-text.doc
Provenge product Label- prelim comments.pdf
LR Provenge PI&PPI FINAL 14Jan10c.pdf
125197 Provenge revised draft-label-(V2-2.23.10).doc

Hi Karen

We would like to request a consult for labeling on our BLA for Provenge. Details for the request are below. I have attached a request form as well.


From: Bross, Peter F (CBER)
Sent: Tuesday, February 23, 2010 1:19 PM
To: Tull, Lori
Cc: George, Bindu; Bryan, Wilson; Zhen, Boguang (CBER)
Subject: Dendreon Provenge CDER BLA labeling consult


Specific questions for CDER:

1. The proposed indication statement reads: “PROVENGE® is indicated for the treatment of men with metastatic castrate resistant (hormone refractory) prostate cancer.” The sipuleucel-T phase 3 studies enrolled patients with asymptomatic or minimally symptomatic “Metastatic Androgen Independent Prostatic Adenocarcinoma.” The taxotere phase 3 prostate cancer studies enrolled patients with symptomatic disease many of whom were receiving narcotic analgesics. The label states “TAXOTERE in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.” Should the sipuleucel-T indication specify that the patients are minimally symptomatic? What is the current correct terminology for hormone refractory prostate cancer?

2. Section 12 on clinical pharmacology includes exploratory studies and speculative statements. Section 14 (clinical studies) contains a lot of detail which we propose to remove. The proposed revised label (V2-2.23.10) with tracked changes is attached. Please comment on the proposed changes.

See attached

Peter F. Bross, MD
Medical Review Officer
Office of Cellular, Tissue, and Gene Therapy, HFM-755
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852
Phone 301 827 5142
Fax 301 827 9796

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