Difference between revisions of "Axicabtagene ciloleucel (Yescarta)"
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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. | ||
<br>'''[https://www.yescartarems.com/ Link to REMS]''' | <br>'''[https://www.yescartarems.com/ Link to REMS]''' | ||
| − | ==Diseases for which it is | + | ==Diseases for which it is established== |
*[[Diffuse large B-cell lymphoma]] | *[[Diffuse large B-cell lymphoma]] | ||
| − | |||
*[[High-grade B-cell lymphoma]] | *[[High-grade B-cell lymphoma]] | ||
*[[Primary mediastinal B-cell lymphoma]] | *[[Primary mediastinal B-cell lymphoma]] | ||
*[[Transformed lymphoma]] | *[[Transformed lymphoma]] | ||
| + | |||
| + | ==Diseases for which it is used== | ||
| + | *[[Follicular lymphoma]] | ||
== Patient Drug Information== | == Patient Drug Information== | ||
Revision as of 00:32, 20 May 2022
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.
Link to REMS
Diseases for which it is established
- Diffuse large B-cell lymphoma
- High-grade B-cell lymphoma
- Primary mediastinal B-cell lymphoma
- Transformed lymphoma
Diseases for which it is used
Patient Drug Information
History of changes in FDA indication
- 10/18/2017: Granted initial 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. (Based on ZUMA-1)
- 3/5/2021: Granted accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. (Based on ZUMA-5)
- 4/1/2022: Approved for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma. (Based on ZUMA-7)
History of changes in EMA indication
- 8/23/2018: Initial marketing authorization as Yescarta.
Also known as
- Code name: KTE-C19
- Generic names: Axicel, Axi-cel
- Brand name: Yescarta
References
Categories:
- Chimeric antigen receptor T-cells
- Anti-CD3 cellular therapy
- Anti-CD20 cellular therapy
- Anti-CD28 cellular therapy
- Intravenous medications
- Diffuse large B-cell lymphoma medications
- Follicular lymphoma medications
- High-grade B-cell lymphoma medications
- Primary mediastinal B-cell lymphoma medications
- Transformed lymphoma medications
- EMA approved in 2018
- FDA approved in 2017
- REMS program
- Kite Pharma product