Breyanzi (lisocabtagene maraleucel) is a CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ and CD4+ T cells, in a defined composition, that have been separately transduced ex vivo using a replication incompetent lentiviral vector expressing an antiCD19 chimeric antigen receptor (CAR) comprising a single chain variable fragment (scFv) binding domain derived from a murine CD19-specific monoclonal antibody (mAb; FMC63) and a portion of the 4-1BB co-stimulatory endodomain and CD3 zeta (ζ) chain signalling domains and a nonfunctional truncated epidermal growth factor receptor (EGFRt).
This medicinal product contains 12.5 mg sodium, 6.5 mg potassium, and 0.35 mL (7.5% v/v) dimethyl sulfoxide per vial.
• Do NOT use a leukodepleting filter. • Ensure tocilizumab or suitable alternatives, in the exceptional case where tocilizumab is not available due to a shortage that is listed in the European Medicines Agency shortage catalogue, and emergency equipment are available prior to infusion and during the recovery period. • Confirm the patient’s identity matches the patient identifiers on the syringe label supplied on the respective release for infusion certificate (RfIC). • Once Breyanzi components have been drawn into syringes, proceed with administration as soon as possible. The total time from removal from frozen storage to patient administration should not exceed 2 hours
Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.