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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (tisagenlecleucel) Autologous T Cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19
Trade Name: Kymriah (tisagenlecleucel)
Date Designated: 01/31/2014
Orphan Designation: For the treatment of Acute Lymphoblastic Leukemia
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corporation
One Health Plaza,
Bldg 315 - Room 3650B
East Hanover, New Jersey 07936
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: (tisagenlecleucel) Autologous T Cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19
Trade Name: Kymriah (tisagenlecleucel)
Marketing Approval Date: 08/30/2017
Approved Labeled Indication: Treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse
Exclusivity End Date: 08/30/2024 
Exclusivity Protected Indication* :  Treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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