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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
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
400 Dexter Ave N
Seattle, Washington 98109
United States

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

Marketing approved:

1 Generic Name: lisocabtagene maraleucel
Trade Name: Breyanzi
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
2 Generic Name: lisocabtagene maraleucel
Trade Name: Breyanzi
Marketing Approval Date: 06/24/2022
Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma (LBCL), 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 who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. Limitations of Use: Breyanzi is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma.
Exclusivity End Date: 06/24/2029 
Exclusivity Protected Indication* :  Treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age (not including treatment of patients with primary central nervous system (CNS) lymphoma and excluding patients covered by the indication that received marketing approval on February 5, 2021 for Breyanzi)
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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