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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 Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma
Exclusivity End Date:    05/01/2025 
Exclusivity Protected Indication* :  For treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma after two or more lines of systemic therapy.
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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