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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: brexucabtagene autoleucel
Trade Name: Tecartus
Date Designated: 04/20/2016
Orphan Designation: Treatment of acute lymphoblastic leukemia (ALL)
Orphan Designation Status: Designated/Approved
Kite Pharma, Inc.
2225 Colorado Avenue
Santa Monica, California 90404
United States

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

Marketing approved:

1 Generic Name: brexucabtagene autoleucel
Trade Name: Tecartus
Marketing Approval Date: 10/01/2021
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory B-cell precursor acute lymphomblastic leukemia (ALL)
Exclusivity End Date: 10/01/2028 
Exclusivity Protected Indication* :  Treatment of adult patients with relapsed or refractory B-cell precursor acute lymphomblastic leukemia (ALL)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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