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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-T
Trade Name:  Kymriah
Date Designated:  02/03/2015
Orphan Designation:  Treatment of diffuse large B-cell lymphoma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  05/01/2018 
Approved Labeled Indication:  KYMRIAH is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of patients with diffuse large B-cell lymphoma, high-grade B-cell lymphoma, or DLBCL arising from follicular lymphoma who received two or more lines of systemic therapy
Exclusivity End Date:   05/01/2025
Novartis Pharmaceuticals Corporation
One Health Plaza,
Bldg 315 - Room 3450B
East Hanover, New Jersey 07936

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