Difference between revisions of "Axicabtagene ciloleucel (Yescarta)"
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m (Jwarner moved page Axicabtagene ciloleucel (KTE-C19) to Axicabtagene ciloleucel (Yescarta): FDA approval) |
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From the [https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=768723 NCI Drug Dictionary]: A preparation of autologous peripheral blood T-lymphocytes (PBTL) that have been transduced with a gammaretroviral vector expressing a chimeric antigen receptor (CAR) consisting of an anti-CD19 single chain variable fragment (scFv) coupled to the costimulatory signaling domain CD28 and the zeta chain of the T-cell receptor (TCR)/CD3 complex (CD3 zeta), with potential immunostimulating and antineoplastic activities. Upon intravenous infusion and re-introduction of axicabtagene ciloleucel into the patient, these cells bind to and induce selective toxicity in CD19-expressing tumor cells. | From the [https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=768723 NCI Drug Dictionary]: A preparation of autologous peripheral blood T-lymphocytes (PBTL) that have been transduced with a gammaretroviral vector expressing a chimeric antigen receptor (CAR) consisting of an anti-CD19 single chain variable fragment (scFv) coupled to the costimulatory signaling domain CD28 and the zeta chain of the T-cell receptor (TCR)/CD3 complex (CD3 zeta), with potential immunostimulating and antineoplastic activities. Upon intravenous infusion and re-introduction of axicabtagene ciloleucel into the patient, these cells bind to and induce selective toxicity in CD19-expressing tumor cells. | ||
| − | == | + | ==Diseases for which it is used== |
| − | + | *[[Diffuse large B-cell lymphoma]]<ref> '''Phase 1:''' Locke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, Ghobadi A, Budde LE, Bot A, Rossi JM, Jiang Y, Xue AX, Elias M, Aycock J, Wiezorek J, Go WY. Phase 1 results of ZUMA-1: A multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in refractory aggressive lymphoma. Mol Ther. 2017 Jan 4;25(1):285-295. Epub 2017 Jan 4. [http://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(16)45375-X link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/28129122 PubMed]</ref> | |
| − | + | *[[Burkitt_lymphoma|High-grade B-cell lymphoma]] | |
| + | *[[Primary mediastinal B-cell lymphoma]] | ||
| + | *[[Transformed lymphoma]] | ||
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | *10/18/2017: Granted initial FDA approval for the treatment of adult patients with relapsed or refractory 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]], [[Primary mediastinal B-cell lymphoma|primary mediastinal large B-cell lymphoma]], [[Burkitt_lymphoma|high-grade B-cell lymphoma]], and [[Transformed lymphoma|DLBCL arising from follicular lymphoma]]. NOT indicated for the treatment of patients with primary central nervous system lymphoma. | ||
==Also known as== | ==Also known as== | ||
| − | + | *'''Code name:''' KTE-C19 | |
| + | *'''Brand name:''' Yescarta | ||
[[Category:Drug index]] | [[Category:Drug index]] | ||
| Line 14: | Line 20: | ||
[[Category:Chimeric antigen receptor T-cells]] | [[Category:Chimeric antigen receptor T-cells]] | ||
| − | [[Category: | + | [[Category:Burkitt lymphoma]] |
| + | [[Category:Diffuse large B-cell lymphoma medications]] | ||
| + | [[Category:Primary mediastinal B-cell lymphoma medications]] | ||
| + | [[Category:Transformed lymphoma medications]] | ||
| + | |||
| + | [[Category:Drugs FDA approved in 2017]] | ||
| + | [[Category:FDA approved drugs]] | ||
Revision as of 16:35, 19 October 2017
Mechanism of action
From the NCI Drug Dictionary: A preparation of autologous peripheral blood T-lymphocytes (PBTL) that have been transduced with a gammaretroviral vector expressing a chimeric antigen receptor (CAR) consisting of an anti-CD19 single chain variable fragment (scFv) coupled to the costimulatory signaling domain CD28 and the zeta chain of the T-cell receptor (TCR)/CD3 complex (CD3 zeta), with potential immunostimulating and antineoplastic activities. Upon intravenous infusion and re-introduction of axicabtagene ciloleucel into the patient, these cells bind to and induce selective toxicity in CD19-expressing tumor cells.
Diseases for which it is used
- Diffuse large B-cell lymphoma[1]
- High-grade B-cell lymphoma
- Primary mediastinal B-cell lymphoma
- Transformed lymphoma
History of changes in FDA indication
- 10/18/2017: Granted initial FDA approval for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. NOT indicated for the treatment of patients with primary central nervous system lymphoma.
Also known as
- Code name: KTE-C19
- Brand name: Yescarta
- ↑ Phase 1: Locke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, Ghobadi A, Budde LE, Bot A, Rossi JM, Jiang Y, Xue AX, Elias M, Aycock J, Wiezorek J, Go WY. Phase 1 results of ZUMA-1: A multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in refractory aggressive lymphoma. Mol Ther. 2017 Jan 4;25(1):285-295. Epub 2017 Jan 4. link to original article PubMed