BREYANZI (lisocabtagene maraleucel)
STN# BLA 125714
Proper Name: lisocabtagene maraleucel
Tradename: BREYANZI
Manufacturer: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Indication:
- For 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; or
- Relapsed or refractory disease after two or more lines of systemic therapy.
- Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma
Product Information
- Package Insert - BREYANZI
- Demographic Subgroup Information – lisocabtagene maraleucel [BREYANZI]
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- June 24, 2022 Approval Letter - BREYANZI
- June 24, 2022 Statistical Reviewer - BREYANZI
- June 24, 2022 Clinical Review Memorandum - BREYANZI
- Clinical Pharmacology Review - BREYANZI
- Summary Basis for Regulatory Action - BREYANZI
- February 5, 2021 Approval Letter - BREYANZI
- Approved Risk Evaluation and Mitigation Strategies (REMS) -BREYANZI
- Approval History, Letters, Reviews and Related Documents - BREYANZI