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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:  04/28/2016
Orphan Designation:  Treatment of mantle cell lymphoma.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  07/24/2020 
Approved Labeled Indication:  TECARTUS™ is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)
Exclusivity End Date:    07/24/2027 
Exclusivity Protected Indication* :  TECARTUS™ is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)
Kite Pharma, Inc.
199 E Blaine St
Seattle, Washington 98102
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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