Breyanzi
Breyanzi Uses, Dosage, Side Effects, Food Interaction and all others data.
Breyanzi is a chimeric antigen receptor (CAR) T-cell therapy, similar to brexucabtagene autoleucel and axicabtagene ciloleucel. Breyanzi is a genetically modified autologous T-cell therapy that targets CD19, the B-lymphocyte surface antigen B4.
CAR T-cell therapy has changed the treatment of B-cell lymphomas, significantly increasing survival rates over standard therapy. However, data on the efficacy of CAR T-cell therapies on less severe forms of B-cell lymphoma are lacking. Despite the adverse reactions, the majority of patients given lisocabtagene maraleucel reported an overall increase in quality of life over a 1 year period.
Breyanzi was granted FDA approval on 5 February 2021.
| Trade Name | Breyanzi |
| Generic | Lisocabtagene maraleucel |
| Lisocabtagene maraleucel Other Names | liso-cel, Lisocabtagene maraleucel |
| Weight | +, |
| Type | Suspension For Intravenous Infusion, Intravenous Suspension |
| Groups | Approved |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | United States, |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Breyanzi is a CAR T-cell therapy for treatment resistant or more severe B-cell lymphomas.
Breyanzi is indicated to treat adults with relapsed or refractory large B-cell lymphoma after ≥2 systemic therapies, diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma.
Breyanzi is also used to associated treatment for these conditions: Grade 3b Follicular Lymphoma, High-grade B-cell Lymphoma (HGBCL), Primary mediastinal large B-cell lymphomas, Refractory Diffuse Large B Cell Lymphoma, Refractory Large B-cell Lymphoma, Relapsed Large B-cell Lymphoma, Relapsed, Diffuse Large B-cell Lymphoma
How Breyanzi works
Breyanzi is chimeric antigen receptor (CAR) T-cell therapy that targets CD19, also known as the B-lymphocyte surface antigen B4. The CAR is composed of an FMC63 monoclonal antibody single chain variable fragment, IgG4 hinge region, CD28 transmembrane domain, 4-1BB costimulatory domain, and CD3ζ activation domain. FMC63 is an IgG2a mouse monoclonal antibody that targets CD19. The IgG4 hinge region can interact with Fcγ receptors to modulate the response of hematopoietic cells. The CD28 transmembrane domain can stimulate the activity or tolerance of T-cells. 4-1BB enhances cytotoxic T-cell activity as well as the production of interferon-γ. The CD23ζ cytoplasmic domain mediates T-cell activation by CD2, a T-cell surface adhesion molecule.
Toxicity
Data regarding overdoses of lisocabtagene maraleucel are not readily available. Patients experiencing an overdose may be experience and increased risk and severity of severe infections, severe and prolonged cytopenia, hypogammaglobulinemia, cytokine release syndrome, and neurological toxicities. In the event of an overdose, initiate symptomatic and supportive measures.
Food Interaction
No interactions found.Elimination Route
Breyanzi reaches a median Cmax of 23928.2 copies/µg with a median AUC of 213730 copies*day/µg. The median time to peak expansion of T-cells was 12 days.
Compared to non-responders, patients with a partial or complete response showed a 3.55-fold increase in Cmax and a 2.72-fold increase in AUC. Compared to non-responders, patients with a higher baseline tumor burden showed a 2.46-fold increase in Cmax, patients with cytokine release syndrome showed a 2.29-fold increase, and patients with neurological events showed a 3.34-fold increase.
Innovators Monograph
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