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  1. Development & Approval Process (CBER)

2021 Biological License Application Approvals

This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval in reverse chronological order.

2021 Biological License Application Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License Number
Approval Date
ABECMA
idecabtagene vicleucel
Indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. 125736/0 Celgene Corporation, a Bristol-Myers Squibb Company
86 Morris Ave.
Summit, NJ 07901

Lic. # 2252
03/26/2021
BREYANZI
lisocabtagene maraleucel
Indicated for the 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. Lisocabtagene maraleucel is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma. 125714/0 Juno Therapeutics, Inc.
400 Dexter Avenue North
Suite 1200
Seattle, WA 98109

Lic. # 2156
02/05/2021

 

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