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 (work in progress)

• Diffuse large B-cell lymphoma
• High-grade B-cell lymphoma
• Primary mediastinal B-cell lymphoma
• Transformed lymphoma

History of changes in FDA indication

• 2/5/2021: 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)

Patient Drug Information

• Lisocabtagene maraleucel (Breyanzi) Package Insert

Also known as

• Code name: JCAR017
• Brand names: Breyanzi, Liso-cel