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LABELS · 6e83a5e5-a286-42e0-b22b-7d5f0b2cb920

BREYANZI

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2026-02-20
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids [see Dosage and Administration ( 2.2 , 2.3 ) and Warnings and Precautions ( 5.1 )] . • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed [see Dosage and Administration ( 2.2 , 2.3 ) and Warnings and Precautions ( 5.2 )] . • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI [see Warnings and Precautions ( 5.7 )] . WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES See full prescribing information for complete boxed warning. • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids. ( 2.2 , 2.3 , 5.1 ) • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed. ( 2.2 , 2.3 , 5.2 ) • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. ( 5.7 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy 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), 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 2 or more lines of systemic therapy. ( 1.1 ) Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma. ( 1 , 14 ) • 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). ( 1.2 ) • adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. ( 1.3 ) • 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. ( 1.4 ) • adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least 2 prior lines of systemic therapy. ( 1.5 ) 1.1 Large B-cell Lymphoma (LBCL) 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), 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 2 or more lines of systemic therapy. Limitations of Use : BREYANZI is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma [see Clinical Studies ( 14.1 )]. 1.2 Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) BREYANZI is indicated for the treatment of 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 [see Clinical Studies ( 14.2 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). 1.3 Follicular Lymphoma (FL) BREYANZI is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. 1.4 Mantle Cell Lymphoma (MCL) BREYANZI is indicated for the treatment of 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. 1.5 Marginal Zone Lymphoma (MZL) BREYANZI is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least 2 prior lines of systemic therapy.
Full extracted label fields
application numbers
  1. BLA125714
boxed warning exact
  1. WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids [see Dosage and Administration ( 2.2 , 2.3 ) and Warnings and Precautions ( 5.1 )] . • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed [see Dosage and Administration ( 2.2 , 2.3 ) and Warnings and Precautions ( 5.2 )] . • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI [see Warnings and Precautions ( 5.7 )] . WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES See full prescribing information for complete boxed warning. • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids. ( 2.2 , 2.3 , 5.1 ) • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed. ( 2.2 , 2.3 , 5.2 ) • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. ( 5.7 )
brand names
  1. BREYANZI
current indication status
not_reconciled
dailymed set url
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generic names
  1. LISOCABTAGENE MARALEUCEL
id
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indications and usage exact
  1. 1 INDICATIONS AND USAGE BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy 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), 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 2 or more lines of systemic therapy. ( 1.1 ) Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma. ( 1 , 14 ) • 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). ( 1.2 ) • adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. ( 1.3 ) • 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. ( 1.4 ) • adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least 2 prior lines of systemic therapy. ( 1.5 ) 1.1 Large B-cell Lymphoma (LBCL) 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), 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 2 or more lines of systemic therapy. Limitations of Use : BREYANZI is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma [see Clinical Studies ( 14.1 )]. 1.2 Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) BREYANZI is indicated for the treatment of 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 [see Clinical Studies ( 14.2 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). 1.3 Follicular Lymphoma (FL) BREYANZI is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. 1.4 Mantle Cell Lymphoma (MCL) BREYANZI is indicated for the treatment of 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. 1.5 Marginal Zone Lymphoma (MZL) BREYANZI is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least 2 prior lines of systemic therapy.
indications and usage tables exact
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    recent major changes exact
    1. Indications and Usage, AA Statement Removed ( 1.3 ) 2/2026 Indications and Usage, MZL ( 1.5 ) 12/2025 Dosage and Administration ( 2.1 ) 12/2025 Dosage and Administration ( 2.2 , 2.3 ) 6/2025 Warnings and Precautions, REMS Removed (5.3) 6/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.4 , 5.6 , 5.8 ) 12/2025
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                    1 INDICATIONS AND USAGE BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy 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), 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-lin
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                                          source url
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                                                  2. abbreviation
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                                                                    application numbers
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                                                                    brand names
                                                                    1. BREYANZI
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                                                                      1.1 Large B-cell Lymphoma (LBCL) 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), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have:
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                                                                      1. BLA125714
                                                                      brand names
                                                                      1. BREYANZI
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                                                                          DLBCL
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                                                                          diffuse large B-cell lymphoma
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                                                                        application numbers
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                                                                        brand names
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                                                                        ry 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 2 or more lines of systemic therapy. Limitations of Use : BREYANZI is not indicated for the treatment of patients with primary central nervous system (CNS) lymp
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                                                                          1. abbreviation
                                                                            FL
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                                                                            follicular lymphoma
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                                                                          2. abbreviation
                                                                            DLBCL
                                                                            definition exact
                                                                            diffuse large B-cell lymphoma
                                                                            definition span
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                                                                            end exclusive
                                                                            true
                                                                            exact text
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                                                                          Passage 21 · unclassified context
                                                                          application numbers
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                                                                          brand names
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                                                                          classification reasons
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                                                                              DLBCL
                                                                              definition exact
                                                                              diffuse large B-cell lymphoma
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                                                                              end exclusive
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                                                                              diffuse large B-cell lymphoma (DLBCL)
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                                                                            unclear
                                                                            Passage 22 · limitation of use
                                                                            application numbers
                                                                            1. BLA125714
                                                                            brand names
                                                                            1. BREYANZI
                                                                            classification reasons
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                                                                            id
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                                                                            label id
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                                                                                  follicular lymphoma
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                                                                                2. abbreviation
                                                                                  DLBCL
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                                                                                  diffuse large B-cell lymphoma
                                                                                  definition span
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                                                                                  236
                                                                                  end exclusive
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                                                                                  diffuse large B-cell lymphoma (DLBCL)
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                                                                                Limitations of Use : BREYANZI is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma [see Clinical Studies ( 14.1 )].
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                                                                                application numbers
                                                                                1. BLA125714
                                                                                brand names
                                                                                1. BREYANZI
                                                                                classification reasons
                                                                                1. explicit_positive_indication_predicate
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                                                                                      This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies ( 14.2 )] .
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                                                                                            brand names
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                                                                                            qualifier mentions
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                                                                                            2. context exact
                                                                                              YANZI is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic
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                                                                                            3. context exact
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                                                                                            regulatory links
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                                                                                              source defined aliases
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                                                                                              2. abbreviation
                                                                                                DLBCL
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                                                                                                diffuse large B-cell lymphoma
                                                                                                definition span
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                                                                                                236
                                                                                                end exclusive
                                                                                                true
                                                                                                exact text
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                                                                                              1.4 Mantle Cell Lymphoma (MCL) BREYANZI is indicated for the treatment of 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.
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                                                                                              application numbers
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                                                                                              brand names
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                                                                                              he treatment of 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. 1.5 Marginal Zone Lymphoma (MZL) BREYANZI is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least 2 prior lines of systemic therapy.
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                                                                                              qualifier mentions
                                                                                              1. context exact
                                                                                                e Lymphoma (MZL) BREYANZI is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) wh
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                                                                                              2. context exact
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                                                                                              regulatory links
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                                                                                                source defined aliases
                                                                                                1. abbreviation
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                                                                                                  follicular lymphoma
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                                                                                                2. abbreviation
                                                                                                  DLBCL
                                                                                                  definition exact
                                                                                                  diffuse large B-cell lymphoma
                                                                                                  definition span
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                                                                                                  end exclusive
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                                                                                                1.5 Marginal Zone Lymphoma (MZL) BREYANZI is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least 2 prior lines of systemic therapy.
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                                                                                                biomarker and test
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                                                                                                limitations
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                                                                                                line
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                                                                                                tumor histology
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                                                                                                use intent
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                                                                                                Preserved source evidence · Not medical advice