(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
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 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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