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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:  07/12/2018
Orphan Designation:  Treatment of primary mediastinal 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) not otherwise specified (including DLBCL arising from indolent lymphoma) 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 N
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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