Breyanzi FDA Approval History
Last updated by Judith Stewart, BPharm on June 30, 2025.
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, Follicular Lymphoma, Mantle Cell Lymphoma
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, chronic lymphocytic leukemia or small lymphocytic lymphoma, follicular lymphoma, and mantle cell lymphoma.
- 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).
- adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy.
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).
- adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor - 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 administered via intravenous infusion.
- 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 cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, edema and diarrhea. Common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease.
- Common adverse reactions in CLL/SLL include cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, edema and diarrhea. Common Grade 3-4 laboratory abnormalities include decreased neutrophil count, decreased white blood cells, decreased hemoglobin, decrease platelet count, and decreased lymphocyte count.
- Common adverse reactions in FL include cytokine release syndrome. Common Grade 3-4 laboratory abnormalities include decreased lymphocyte count, decreased neutrophil count, and decreased white blood cells.
- Common adverse reactions in MCL are cytokine release syndrome, fatigue, musculoskeletal pain, and encephalopathy. Common Grade 3-4 laboratory abnormalities include decreased neutrophil count, decreased white blood cells, and decreased platelet count.
Development timeline for Breyanzi
Further information
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