Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Breyanzi 1.1-70 × 106 cells/mL / 1.1-70 × 106 cells/mL dispersion for infusion.
| Pharmaceutical Form |
|---|
|
Dispersion for infusion (infusion). Slightly opaque to opaque, colourless to yellow, or brownish-yellow dispersion. |
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).
Breyanzi contains CAR+ viable T cells, consisting of a defined composition of CD8+ and CD4+ cell components:
CD8+ cell component:
Each vial contains lisocabtagene maraleucel at a batch-specific concentration of autologous T cells genetically modified to express anti-CD19 chimeric antigen receptor (CAR+ viable T cells). The medicinal product is packaged in one or more vials containing a cell dispersion of 5.1-322 × 106 CAR+ viable T cells (1.1-70 × 106 CAR+ viable T cells/mL) suspended in a cryopreservative solution.
Each vial contains 4.6 mL of CD8+ cell component.
CD4+ cell component:
Each vial contains lisocabtagene maraleucel at a batch-specific concentration of autologous T cells genetically modified to express anti-CD19 chimeric antigen receptor (CAR+ viable T cells). The medicinal product is packaged in one or more vials containing a cell dispersion of 5.1-322 × 106 CAR+ viable T cells (1.1-70 × 106 CAR+ viable T cells/mL) suspended in a cryopreservative solution.
Each vial contains 4.6 mL of CD4+ cell component.
More than one vial of each of the CD8+ cell component and/or CD4+ cell component may be needed to achieve the dose of Breyanzi. The total volume to be dosed and the number of vials required may differ for each cell component.
The quantitative information for each cell component of the medicinal product is presented in the respective release for infusion certificate (RfIC) affixed inside the shipper. The RfIC for each component includes the total volume to be dosed, the number of vials required and the volume to be dosed from each vial, based on the cryopreserved CAR+ viable T cell concentration.
Excipients with known effect: This medicinal product contains 12.5 mg sodium, 6.5 mg potassium, and 0.35 mL (7.5% v/v) dimethyl sulfoxide per vial (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lisocabtagene maraleucel |
Lisocabtagene maraleucel is a CD19-directed genetically modified autologous cellular immunotherapy administered as a defined composition to reduce variability in CD8+ and CD4+ T-cell dose. CAR binding to CD19 expressed on the cell surface of tumour and normal B cells induces activation and proliferation of CAR T cells, release of pro-inflammatory cytokines, and cytotoxic killing of target cells. |
| List of Excipients |
|---|
|
Cryostor CS10 |
Breyanzi is supplied in cryopreservation vials made of cyclic olefin copolymer. Each 5 mL vial contains 4.6 mL cell dispersion.
The CAR+ viable T cells (CD8+ cell component or CD4+ cell component) are presented in individual cartons containing up to 4 vials of each component, depending upon the cryopreserved drug product CAR+ viable T cell concentration.
The cartons of CD8+ cell component and CD4+ cell component are contained in a single outer carton.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
EU/1/22/1631/001
| Drug | Countries | |
|---|---|---|
| BREYANZI | Estonia, Croatia, Lithuania, Poland, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
