Breyanzi FDA Approval History
Last updated by Judith Stewart, BPharm on March 16, 2024.
FDA Approved: Yes (First approved February 5, 2021)
Brand name: Breyanzi
Generic name: lisocabtagene maraleucel
Dosage form: Suspension for Intravenous Infusion
Company: Bristol-Myers Squibb Company
Treatment for: Diffuse Large B-Cell Lymphoma, B-Cell Lymphoma, Chronic Lymphocytic Leukemia
Breyanzi (lisocabtagene maraleucel) is a CD-19 directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Breyanzi is indicated for the 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), highgrade 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.
- adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- The Breyanzi product label carries a boxed warning advising the risk of Cytokine Release Syndrome (CRS) and neurologic toxicities which can be fatal or life-threatening, and secondary hematological malignancies. Breyanzi is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Breyanzi REMS.
- Breyanzi is administered via intravenous infusion in a certified healthcare facility.
- Breyanzi may cause serious adverse reactions including hypersensitivity reactions, serious infections, prolonged cytopenias, hypogammaglobulinemia and secondary malignancies.
- Patients receiving Breyanzi should refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery for at least 8 weeks.
- Common adverse reactions in LBCL include fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. Common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease.
Common adverse reactions in CLL/SLL include cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease.
Development timeline for Breyanzi
Further information
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