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U.S. Department of Health and Human Services

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CMC Review Memo, June 11, 2013 - HPC, Cord Blood BLA 125432

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 

From: Wilson W. Bryan, M.D., Director,
Division of Clinical Evaluation and Pharmacology / Toxicology, OCTGT, CBER
 
Date:   June 11, 2013
 
BLA/ STN#: 125432
 
Applicant Name: LifeSouth Community Blood Centers, Inc.
 
Action Goal Date: June 17, 2013
 
Proprietary Name/ Established Name: None
 
Non-Proprietary name: HPC, Cord Blood
 
Indication: HPC, Cord Blood is an allogeneic cord blood hematopoietic progenitor cell therapy intended for use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.  The risk benefit assessment for an individual patient depends on the patient characteristics, including disease, stage, risk factors, and specific manifestations of the disease, on characteristics of the graft, and on other available treatments or types of hematopoietic progenitor cells.
 
Clinical and Statistical Reviewers: Mark Borigini, M.D. (clinical); Stan Lin, Ph.D. (statistical)
 
Statistical Team Leader: Shiowjen Lee, Ph.D. (statistical)
 
Clinical and Statistical Branch Chiefs: Ilan Irony, M.D. (clinical); Boguang Zhen, Ph.D. (statistical)
 
Material Reviewed/ Consulted: Clinical/Statistical Review of Original Submission, dated June 11, 2013
  
I agree with the recommendation for approval as stated in the clinical/statistical review memo dated June 11, 2013, and have no additional comments. 
 
  
___________________________________

Wilson W. Bryan, M.D.