Lisocabtagene maraleucel (Breyanzi)

==Mechanism of action==
From the NCI Drug Dictionary: A preparation of a defined ratio of CD4+ and CD8+ autologous T lymphocytes transduced with a lentiviral vector expressing a chimeric antigen receptor (CAR) containing an anti-CD19 single chain variable fragment (scFv) fused to the signaling domain of 4-1BB (CD137), the zeta chain of the TCR/CD3 complex (CD3-zeta), and a truncated form of the human epidermal growth factor receptor (EGFRt), with potential immunostimulating and antineoplastic activities. Upon intravenous administration, lisocabtagene maraleucel is directed to and induce selective toxicity in CD19-expressing tumor cells.
==Toxicity management==
*Link to REMS program
==Diseases for which it is established==
*Diffuse large B-cell lymphoma
*High-grade B-cell lymphoma
*Mantle cell lymphoma
*Primary mediastinal B-cell lymphoma
*Transformed lymphoma
==Diseases for which it is used==
*Chronic lymphocytic leukemia
*Follicular lymphoma
==History of changes in FDA indication==
*2021-02-05: Approved 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. (Based on TRANSCEND NHL-001)
*2022-06-24: Approved for adult patients with large B-cell lymphoma (LBCL) who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy. (Based on TRANSFORM)
*2022-06-24: Approved for adult patients with large B-cell lymphoma (LBCL) who have refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. (Based on TRANSFORM)
*2024-05-15: Granted accelerated approval for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. (Based on TRANSCEND-FL)
*2024-05-30: Approved for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor (BTKi). (Based on TRANSCEND-MCL)
==History of changes in EMA indication==
*2022-04-04: Breyanzi is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after two or more lines of systemic therapy.
*2023-05-25: Revised indication 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.
==History of changes in Health Canada indication==
*2022-05-06: Initial notice of compliance
==History of changes in PMDA indication==
*2021-03-22: Initial approval
== Patient Drug Information==
*Lisocabtagene maraleucel (Breyanzi) Package InsertLisocabtagene maraleucel (Breyanzi) Package Insert
==Also known as==
*Code name: JCAR-017
*Generic name: liso-cel
*Brand name: Breyanzi
==References==
Category:Anti-CD19 CAR T-cells
Category:Anti-CD3 cellular therapy
Category:Anti-CD19 cellular therapy
Category:Anti-CD137 cellular therapy
Category:Intravenous medications
Category:Chronic lymphocytic leukemia medications
Category:Diffuse large B-cell lymphoma medications
Category:Follicular lymphoma medications
Category:High-grade B-cell lymphoma medications
Category:Mantle cell lymphoma medications
Category:Primary mediastinal B-cell lymphoma medications
Category:Transformed lymphoma medications
Category:REMS program
Category:FDA approved in 2021
Category:EMA approved in 2022
Category:Health Canada approved in 2022
Category:PMDA approved in 2021
Category:Bristol-Myers Squibb product