
 

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.

Thanks!
Lori


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

Lori:

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
Peter.Bross@fda.hhs.gov
 
