Difference between revisions of "Lisocabtagene maraleucel (Breyanzi)"

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From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/778386 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.
 
From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/778386 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.
  
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==Preliminary data==
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==Toxicity management==
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===[[Diffuse large B-cell lymphoma]]===
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*[https://www.breyanzirems.com Link to REMS program]
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*'''TRANSCEND-NHL-001:''' Abramson JS, Palomba ML, Gordon LI, Lunning MA, Wang M, Arnason J, Mehta A, Purev E, Maloney DG, Andreadis C, Sehgal A, Solomon SR, Ghosh N, Albertson TM, Garcia J, Kostic A, Mallaney M, Ogasawara K, Newhall K, Kim Y, Li D, Siddiqi T. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020 Sep 19;396(10254):839-852. Epub 2020 Sep 1. [https://doi.org/10.1016/s0140-6736(20)31366-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32888407 PubMed] NCT02631044
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==Diseases for which it is established==
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*[[Diffuse large B-cell lymphoma]]
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*[[High-grade B-cell lymphoma]]
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*[[Mantle cell lymphoma]]
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*[[Primary mediastinal B-cell lymphoma]]
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*[[Transformed lymphoma]]
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==Diseases for which it is used==
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*[[Chronic lymphocytic leukemia]]
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*[[Follicular lymphoma]]
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==History of changes in FDA indication==
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*2024-05-15: Granted accelerated approval for adults with relapsed or refractory [[Follicular lymphoma|follicular lymphoma (FL)]] who have received two or more prior lines of systemic therapy. ''(Based on TRANSCEND-FL)''
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*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|diffuse large B-cell lymphoma (DLBCL) not otherwise specified]] (including [[Transformed lymphoma|DLBCL arising from indolent lymphoma]]), [[high-grade B-cell lymphoma]], [[Primary mediastinal B-cell lymphoma|primary mediastinal large B-cell lymphoma]], and follicular lymphoma grade 3B. ''(Based on TRANSCEND NHL-001)''
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*2022-06-24: Approved for adult patients with [[Diffuse large B-cell lymphoma|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)''
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*2022-06-24: Approved for adult patients with [[Diffuse large B-cell lymphoma|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)''
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*2024-05-30: Approved for adult patients with relapsed or refractory [[mantle cell lymphoma|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)''
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==History of changes in EMA indication==
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*2022-04-04: Breyanzi is indicated for the treatment of adult patients with relapsed or refractory [[Diffuse large B-cell lymphoma|diffuse large B-cell lymphoma (DLBCL)]], [[Primary mediastinal B-cell lymphoma|primary mediastinal large B-cell lymphoma (PMBCL)]] and follicular lymphoma grade 3B (FL3B), after two or more lines of systemic therapy.
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*2023-05-25: Revised indication for the treatment of adult patients with [[Diffuse large B-cell lymphoma|diffuse large B-cell lymphoma (DLBCL)]], [[High-grade B-cell lymphoma|high grade B-cell lymphoma (HGBCL)]], [[Primary mediastinal B-cell lymphoma|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.
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==History of changes in Health Canada indication==
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*2022-05-06: Initial notice of compliance
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==History of changes in PMDA indication==
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*2021-03-22: Initial approval
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== Patient Drug Information==
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*[https://www.fda.gov/media/145711/download Lisocabtagene maraleucel (Breyanzi) Package Insert]<ref>[https://www.fda.gov/media/145711/download Lisocabtagene maraleucel (Breyanzi) Package Insert]</ref>
  
 
==Also known as==
 
==Also known as==
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*'''Code name:''' JCAR017
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*'''Code name:''' JCAR-017
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*'''Brand name:''' Liso-cel
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*'''Generic name:''' liso-cel
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*'''Brand name:''' Breyanzi
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==References==
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[[Category:Anti-CD19 CAR T-cells]]
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[[Category:Anti-CD3 cellular therapy]]
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[[Category:Anti-CD19 cellular therapy]]
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[[Category:Anti-CD137 cellular therapy]]
  
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[[Category:Chimeric antigen receptor T-cells]]
 
 
[[Category:Intravenous medications]]
 
[[Category:Intravenous medications]]
  
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[[Category:Chronic lymphocytic leukemia medications]]
 
[[Category:Diffuse large B-cell lymphoma medications]]
 
[[Category:Diffuse large B-cell lymphoma medications]]
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[[Category:Follicular lymphoma medications]]
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[[Category:High-grade B-cell lymphoma medications]]
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[[Category:Mantle cell lymphoma medications]]
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[[Category:Primary mediastinal B-cell lymphoma medications]]
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[[Category:Transformed lymphoma medications]]
  
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[[Category:Investigational drugs]]
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[[Category:REMS program]]
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[[Category:FDA approved in 2021]]
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[[Category:EMA approved in 2022]]
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[[Category:Health Canada approved in 2022]]
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[[Category:PMDA approved in 2021]]
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[[Category:Bristol-Myers Squibb product]]

Revision as of 03:31, 1 June 2024

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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