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Vaccines, Blood & Biologics

RE: Discussion of Dendreon Pharmacovigilance Plan (Internal) - Provenge, February 18, 2010

(System Info - 126756 Lavoie Deborah 04/22/2010 18:44:55 TULL)

From:              Ball, Robert
Sent:              Thursday, February 18, 2010 5:18 PM
To:                 Witten, Celia (CBER); Tull, Lori; Simek, Stephanie; Wise, Robert; Bross, Peter F (CBER); George,
                       Bindu; Fan, Chaohong; Bryan, Wilson; Zhen, Boguang (CBER); Gupta, Ghanshyam; Wilson,
Subject:           RE: Discussion of Dendreon Pharmacovigilance Plan (Internal)

From what I have read and heard from OBE staff, I do not think OBE's position is that different from what
Celia has written below, except that perhaps we take a more linear approach to the decision about PMR vs
PMC, which I will outline to clarify OBE's perspective to focus the discussion tomorrow.

The approach we take to this issue is first to ask the question "Is there a serious safety risk or a signal of a
serious safety risk?" If yes, but it does not preclude licensure or require a REMS (generally meaning it is
not a strong signal), then we ask "Does it meet one of the criteria in the FDA AA for a PMR?" If yes, then
we ask "what is the ideal study?" and "what is an achievable study?", where by achievable we mean a study
that will add to our knowledge of the risk in the context of the disease and the benefit of the product. In
looking at the issue in this way, the question of the study design itself is separate from the question of is
there a signal and should there be a PMR.

So I think the focus of the discussion tomorrow might be: first, do we agree on this linear approach to the
PMR vs PMC determination? Second, do we agree there is a weak signal that meets the FDA AA criteria
for a PMR? And finally, can the sponsor's proposal be tweaked to get better or more focused information to
help inform us about the risk without requiring a major trial?I look forward to a productive

From:            Witten, Celia (CBER)
Sent:            Thursday, February 18, 2010 4:58 PM
To:               Tull, Lori; Simek, Stephanie; Ball, Robert; Wise, Robert; Bross, Peter F (CBER); George, Bindu;
                    Fan, Chaohong; Bryan, Wilson; Zhen, Boguang (CBER); Gupta, Ghanshyam; Wilson, Rickey
Subject:        RE: Discussion of Dendreon Pharmacovigilance Plan (Internal)

Thanks for being willing to participate in this meeting tomorrow at short notice. Now that I understand the
situation better, I am concerned about the idea of needing a PMC for this product, especially to evaluate the
risk of stroke; if there is a signal of an increased risk of stroke the increase would be expected to be quite
small and to substantiate that risk would require an enormous study which I do not think is warranted in this

The sponsor has proposed a sizable (1500 patient) registry. I don't think that it can answer the question
about a less than one percent increase risk of stroke compared to untreated although it will provide valuable
additional safety information.

Celia M.Witten, Ph.D., M.D.
Director, Office of Cellular, Tissue, and Gene Therapy
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Woodmont 1, HFM 700
Rockville, Md. 20852
(FAX) 301-827-9796
PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to
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From:           Tull, Lori
Sent:           Thursday, February 18, 2010 1:26 PM
To:              Tull, Lori; Tull, Lori; Witten, Celia (CBER); Simek, Stephanie; Ball, Robert; Wise, Robert; Bross,
                   Peter F (CBER); George, Bindu; Fan, Chaohong; Bryan, Wilson; Zhen, Boguang (CBER); Gupta,
                   Ghanshyam; Wilson, Rickey
Cc:               Finn, Thomas; Benton, Kimberly; Puri, Raj K. (FDA/CBER); Wonnacott, Keith
Subject:        Updated: Discussion of Dendreon Pharmacovigilance Plan (Internal)
When:           Friday, February 19, 2010 10:00 AM-11:00 AM (GMT-05:00) Eastern Time (US & Canada).
Where:          CBER Conf. WOC 1 COOP conference room 5th floor


Unfortunately, there are no conference rooms available, so we will need to do this by phone. The dial in
number is below.

Rescheduling for 10-11 in the COOP conference room. Please respond.

Please see the attached emails regarding the PMR/PMC for Dendreon. Dr. Witten requested that we have an
internal meeting to discuss.

Please respond as soon as possible.

Dial in 1-866-761-2513 passcode (b)(2)

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