FDA Required List Email, September 29, 2011

From:  Zhu, Yao-Yao
To:  "kurtz001@mc.duke.edu";
cc:  Przepiorka, Donna; Davidson, Mark;
Subject:  RE: FDA required list
Date:  Thursday, September 29, 2011 3:43:04 PM

Dear Dr. Kurtzberg,

As per our T'con discussion at 10 AM today, please see following list of FDA required variables for your cord blood BLA. Please submit all required datasets within a week (not more than 2 weeks) so we can initiate our review process as soon as possible.

List of minimal requirement of variables on the Cord-blood BLA data sets:

Data on the cord blood units should include at a minimum,

     the recipient ID
     unit ID
     degree of HLA mismatch
     recipient weight
     TNC dose and TNC/kg dose at cryopreservation
     processing method
     date stored
     date transplanted
     donor ineligibility reason (if any)
     reaction to infusion.

Data on the patients transplanted should include at a minimum

     the recipient ID
     age (in days) or date of birth
     gender
     race/ethnicity
     diagnosis
     transplant date
     TCBB IDs of cord blood units transplanted
     total number of units (TCBB plus nonTCBB units) transplanted
     total TNC/kg (at cryopreservation)
     degree of HLA mismatch (worst degree for multiple unit transplants)
     date of neutrophil recovery
     date of platelet recovery
     graft failure (primary or secondary)
     date censoring for competing risks of engraftment (autologous recovery, boost or second transplantation, relapse)
     maximum grade of acute GVHD
     date of last follow-up
     date of death
     cause of death

Any additional variable that you used in the analyses submitted or that will assist in the evaluation of the safety of the product.

Thank you! Yao-Yao Zhu, Clinical Reviewer

Yao-Yao Zhu, MD, PhD
Medical Officer, Division of Clinical Evaluation and Pharmacology/Toxicology Review
Office of Cellular, Tissue, and Gene Therapies
Center for Biologic Evaluation and Research
Food and Drug Administration
e-mail: yao-yao.zhu@fda.hhs.gov
Tel: (301)827-9141

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Yao-Yao Zhu, MD, PhD