Choose Breyanzi®: THE ONE for adults with R/R MCL after ≥2 prior lines of systemic therapy, including a BTKi1

Breyanzi is THE ONE CAR T studied in a broad range of patients with 3L+ MCL, including those with the following features1,2

Median age

69% of patients had
disease refractory
to last therapy

High-risk features

Patients had
high-risk features,
including Ki67 ≥30% (77%),
complex karyotype (31%),
blastoid morphology (29%),
and TP53 mutation (25%)

Median age: 69
(range: 36-86)

3 median prior therapies
(range: 2-11)

ECOG PS 0/1:
57%/43% of patients

Patients of Breyanzi

A patient eligible for Breyanzi in MCL1,2:

  • Has R/R disease after at least 2 prior lines of systemic therapy, including a BTKi
  • Has no upper age limit
  • Can have standard- or high-risk disease features (blastoid morphology, Ki67 proliferation index ≥30%, and TP53 mutation)

Identify eligible patients early, and seek consultation with a CAR T-cell
therapy treatment center to evaluate them for Breyanzi

TRANSCEND MCL Cohort trial design (N=68): TRANSCEND MCL was an open-label, multicenter, single-arm trial of adult patients with R/R MCL who received ≥2 prior lines of systemic therapy, including a BTKi. The primary endpoints were ORR and safety.1,3

Do you have patients like these in your practice? Breyanzi may be the right one for them

Hypothetical Breyanzi MCL patient Jim

Jim*

  • 69 years old
  • Board member of a food bank who practices Tai Chi and is interested in helping his community
  • Adult daughter lives nearby and helps care for him
MCL stage at diagnosis
  • 2
Risk factors

Risk factors

  • sMIPI score 4 (intermediate risk)
  • Ki67 >30%
Prior therapies

Prior therapies

  • 1L: BR followed by rituximab maintenance
  • Complete response, 3 years
  • 2L: BTKi
  • Complete response, 1 year
Clinical fitness

Clinical fitness

  • ECOG PS: 1

Relevant comorbidities

  • Mild heart disease (LVEF 52%)

*Hypothetical patient.

1L, first-line; 2L, second-line; 3L, third-line; BR, bendamustine and rituximab; BTKi, Bruton tyrosine kinase inhibitor; CAR, chimeric antigen receptor; ECOG PS, Eastern Cooperative Oncology Group performance status; LVEF, left ventricular ejection fraction; MCL, mantle cell lymphoma; ORR, overall response rate; R/R, relapsed or refractory; sMIPI, simplified Mantle Cell Lymphoma International Prognostic Index; TP53, tumor protein 53.

Hypothetical Breyanzi MCL patient Luis

Luis*

  • 66 years old
  • Owner of a bike shop who lives in a rural town in the mountains of Colorado. Luis is an avid fisherman and wants to continue leading an active life
  • Adult son lives nearby and provides support when needed
MCL stage at diagnosis
  • 4
Risk factors

Risk factors

  • TP53 mutation
  • Ki67 >30%
Prior therapies

Prior therapies

  • 1L: NORDIC regimen followed by HDT/SCT + rituximab maintenance
  • Complete response, 2 years
  • 2L: BTKi
  • Partial response, 9 months
Clinical fitness

Clinical fitness

  • ECOG PS: 0

Relevant Comorbidities

  • None

*Hypothetical patient.

1L, first-line; 2L, second-line; 3L, third-line; BTKi, Bruton tyrosine kinase inhibitor; CAR, chimeric antigen receptor; ECOG PS, Eastern Cooperative Oncology Group performance status; HDT, high-dose therapy; MCL, mantle cell lymphoma; ORR, overall response rate; R/R, relapsed or refractory; SCT, stem cell transplantation; TP53, tumor protein 53.

References

  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2025.
  2. Data on file. BMS-REF-LIS-0051. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
  3. Wang M, Siddiqi T, Gordon LI, et al. Lisocabtagene maraleucel in relapsed/refractory mantle cell lymphoma: primary analysis of the mantle cell lymphoma cohort from TRANSCEND NHL 001, a phase I multicenter seamless design study. J Clin Oncol. 2024;42(10):1146-1157. doi:10.1200/JCO.23.02214
  4. Armitage JO, Longo DL. Mantle-cell lymphoma. N Engl J Med. 2022;386(26):2495-2506. doi:10.1056/NEJMra2202672

Important Safety Information

Indication

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy 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.

Important Safety Information

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.
  • 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.
  • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI.

Cytokine Release Syndrome

Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 54% of patients, including ≥ Grade 3 CRS in 3.2% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 98% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥10%) were fever, hypotension, tachycardia, chills, hypoxia, and headache.

Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI.

Neurologic Toxicities

Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred.

In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 31% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7 days (range: 1 to 119 days). Of patients developing neurotoxicity, 82% also developed CRS.

The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, headache, dizziness, and delirium.

CRS and Neurologic Toxicities Monitoring

Monitor patients daily for at least 7 days following BREYANZI infusion for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Continue to monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 2 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Advise patients to avoid driving for at least 2 weeks following infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time.

Hypersensitivity Reactions

Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).

Serious Infections

Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in 34% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.7%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI.

Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections.

Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines.

Prolonged Cytopenias

Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration.

Hypogammaglobulinemia

B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 10% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated.

Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI.

Secondary Malignancies

Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing.

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS)

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines.

Adverse Reactions

The most common adverse reactions (incidence ≥30%) in MCL are cytokine release syndrome, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

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2009-US-2500228

09/2025