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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  lisocabtagene maraleucel
Trade Name:  Breyanzi
Date Designated:  04/27/2016
Orphan Designation:  Treatment of diffuse large B-cell lymphoma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  02/05/2021 
Approved Labeled Indication:  treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B
Exclusivity End Date:    02/05/2028 
Exclusivity Protected Indication* :  treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy; treatment of adult patients with relapsed or refractory primary mediastinal large B-cell lymphoma after two or more lines of systemic therapy; and treatment of adult patients with relapsed or refractory follicular lymphoma grade 3B after two or more lines of systemic therapy
Juno Therapeutics, Inc.
400 Dexter Avenue North
Suite 1200
Seattle, Washington 98109
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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