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. | ||
| − | == | + | ==Diseases for which it is used== |
| − | + | *[[Diffuse large B-cell lymphoma]] | |
| − | *'''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 | + | *[[High-grade B-cell lymphoma]] |
| + | *[[Primary mediastinal B-cell lymphoma]] | ||
| + | *[[Transformed lymphoma]] | ||
| + | #'''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 | ||
| + | |||
| + | ==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|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. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' JCAR017 | *'''Code name:''' JCAR017 | ||
| − | *'''Brand | + | *'''Brand names:''' Breyanzi, Liso-cel |
[[Category:Chimeric antigen receptor T-cells]] | [[Category:Chimeric antigen receptor T-cells]] | ||
| Line 14: | Line 20: | ||
[[Category:Diffuse large B-cell lymphoma medications]] | [[Category:Diffuse large B-cell lymphoma medications]] | ||
| + | [[Category:Primary mediastinal B-cell lymphoma medications]] | ||
| + | [[Category:Transformed lymphoma medications]] | ||
| − | [[Category: | + | [[Category:FDA approved in 2021]] |
Revision as of 02:07, 6 February 2021
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.
Diseases for which it is used
- Diffuse large B-cell lymphoma
- High-grade B-cell lymphoma
- Primary mediastinal B-cell lymphoma
- Transformed lymphoma
- 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. link to original article PubMed NCT02631044
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.
Also known as
- Code name: JCAR017
- Brand names: Breyanzi, Liso-cel