Breyanzi ® – CD19-directed CAR T cell therapy administered as a defined composition of purified * CD8 and CD4 CAR-positive T cells ; for adults with R / R large B-cell lymphoma † after ≥2 lines of systemic therapy . 1
Breyanzi CAR T cell therapy
SMARTMADE SMARTER
T cells are smart : naturally detecting and eliminating tumor cells — but cancer can evade the body ’ s defenses . 2
Breyanzi is your patient ’ s T cells made smarter : CAR T cells engineered to target and kill CD19-expressing B cells . 1
CAR , chimeric antigen receptor ; DLBCL , diffuse large B-cell lymphoma ; FL , follicular lymphoma ; PMBCL , primary mediastinal large B-cell lymphoma .
* The purified CD8-positive and CD4-positive T cells are separately activated and transduced with the replication-incompetent lentiviral vector containing the anti-CD19 CAR transgene . † Including DLBCL not otherwise specified ( including DLBCL arising from indolent lymphoma ), high-grade B-cell lymphoma , PMBCL , and FL Grade 3B .
Indication
BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory ( R / R ) large B-cell lymphoma after two or more lines of systemic therapy , 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 .
Limitations of Use : BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma .
Important Safety Information
WARNING : CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES
• 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 .
• BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy ( REMS ) called the BREYANZI REMS .
Cytokine Release Syndrome ( CRS ): CRS , including fatal or life-threatening reactions , occurred following treatment with BREYANZI . CRS occurred in 46 % ( 122 / 268 ) of patients receiving BREYANZI , including ≥ Grade 3 ( Lee grading system ) CRS in 4 % ( 11 / 268 ) of patients . One patient had fatal CRS and 2 had ongoing CRS at time of death . The median time to onset was 5 days ( range : 1 to 15 days ). CRS resolved in 119 of 122 patients ( 98 %) with a median duration of 5 days ( range : 1 to 17 days ). Median duration of CRS was 5 days ( range 1 to 30 days ) in all patients , including those who died or had CRS ongoing at time of death .
Among patients with CRS , the most common manifestations of CRS include fever ( 93 %), hypotension ( 49 %), tachycardia ( 39 %), chills ( 28 %), and hypoxia ( 21 %). 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 . Please see additional Important Safety Information and Brief Summary of full Prescribing Information , including Boxed WARNINGS on following pages .