Lisocabtagene maraleucel (Breyanzi)

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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

Diseases for which it is established

Diseases for which it is used

History of changes in FDA indication

  • 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)
  • 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)
  • 2024-05-30: 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

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

Also known as

  • Code name: JCAR-017
  • Generic name: liso-cel
  • Brand name: Breyanzi

References

  1. ↑ Lisocabtagene maraleucel (Breyanzi) Package Insert
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