


Questions for Dendreon - Provenge, May 27, 2010




 
(System Info - 126752 Lavoie Deborah 04/22/2010 18:34:45 TULL)

From: Bross, Peter F (CBER)
 Sent: Friday, February 19, 2010 8:06 PM
 To: Tull, Lori; 'Smith, Liz'
 Subject: Questions for Dendreon

Liz:

So sorry I am sending these questions so late - they were in my outbox but I 
forgot to press ?send.?
  .. We are evaluating the label regarding product expiration times from a 
  clinical perspective. Currently the draft label reads ?Infusion must begin 
  prior to the expiration date and time indicated on the Product.? If Dendreon 
  has information regarding time from manufacture to actual infusion of product 
  please provide this information or explain where it is provided in the BLA. 
  Please provide any information regarding any evidence of a correlation with 
  increased product storage time and either safety or efficacy measures such as 
  exploratory analyses comparing the timing of the product infusion (in relation 
  to shelf life) with survival times. An analysis comparing survival times of 
  patients infused with product less than median time from manufacture to 
  infusion compared with product infusion initiated at greater than the median 
  time from manufacture to infusion would be helpful. Additional exploratory 
  analyses based on product storage time periods or timing as a continuous 
  variable would also be helpful. We are specifically interested in the efficacy 
  and safety analysis of those subjects who received infusions (either initiated 
  or completed infusions) close to or beyond the expiration time. Also please 
  provide any information regarding effects on length of time from manufacture 
  to infusion on product safety.
  .. Please summarize information including training and SOPPs you may have 
  provided in order to assist investigators regarding clinical management of 
  infusion-related adverse reactions especially with respect to stopping or 
  slowing the infusions. You may also include a proposal to revise the label in 
  order to help clarify management of adverse infusion reactions.

We hope to initiate clinical labeling discussions soon.

-Peter

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

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