CMC Review Memo, May 23, 2013 - ALLOCORD

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 
                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 
MEMORANDUM
 
 
From:   Kimberly Benton, Ph.D., Deputy Director, Division of Cellular & Gene Therapies
Raj Puri, M.D., Ph.D., Director, Division of Cellular & Gene Therapies, OCTGT, CBER
Date:   May 23, 2013
BLA/ STN#: 125413
Applicant Name: SSM Cardinal Glennon Children’s Medical Center, St. Louis Cord Blood Bank
Date of Submission: October 19, 2011 (original submission); December 13, 2012 (response to FDA Complete Response letter dated August 16, 2012)
Action Goal Date: June 15, 2013
Proprietary Name/ Established Name: ALLOCORD
Non-Proprietary name: HPC, Cord Blood
Indication: ALLOCORD 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.
Product Reviewers: Brenton McCright, Ph.D.,Brian Niland, Ph.D., Safa Karandish, B.S., MT (ASCP), Joydeep Ghosh, Ph.D.
Branch Chief: Keith Wonnacott,Ph.D.
Material Reviewed/ Consulted:
CMC Review of Original Submission dated August 16, 2012
FDA Complete Response Letter dated August 16, 2012
CMC Review of Resubmission dated May 22, 2013
 
 
I agree with the recommendation for approval as stated in the CMC review memo dated May 22, 2013, and have no additional comments. 
 
 
 
 
___________________________________             __________________________________
               Kimberly Benton, Ph.D.                                          Raj K. Puri, M.D., Ph.D.