Difference between revisions of "Axicabtagene ciloleucel (Yescarta)"
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==Mechanism of action== | ==Mechanism of action== | ||
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 | + | ==Toxicity management== |
| + | *'''[https://www.yescartarems.com/ Link to REMS]''' | ||
| + | ==Diseases for which it is established ''(work in progress)''== | ||
*[[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== | ||
| − | *[https://www. | + | *[https://www.gilead.com/-/media/files/pdfs/medicines/oncology/yescarta/yescarta-pi.pdf Axicabtagene ciloleucel (Yescarta) Package Insert]<ref>[https://www.gilead.com/-/media/files/pdfs/medicines/oncology/yescarta/yescarta-pi.pdf Axicabtagene ciloleucel (Yescarta) Package Insert]</ref> |
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *10 | + | *2017-10-18: 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|diffuse large B-cell lymphoma (DLBCL) not otherwise specified]], [[Primary mediastinal B-cell lymphoma|primary mediastinal large B-cell 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. ''(Based on ZUMA-1)'' |
| − | * | + | *2021-03-05: Granted accelerated approval for adult patients with relapsed or refractory [[Follicular lymphoma|follicular lymphoma (FL)]] after two or more lines of systemic therapy. ''(Based on ZUMA-5)'' |
| + | *2022-04-01: Approved for adult patients with [[diffuse large B-cell lymphoma|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== | ||
| + | *2018-08-23: Initial marketing authorization as Yescarta. Yescarta is indicated for the treatment of adult patients with relapsed or refractory [[diffuse large B-cell lymphoma|diffuse large B-cell lymphoma (DLBCL)]] and [[Primary mediastinal B-cell lymphoma|primary mediastinal large B-cell lymphoma (PMBCL)]], after two or more lines of systemic therapy. ''(Based on ZUMA-1)'' | ||
| + | *2022-06-21: Extension of indication to include the treatment of adult patients with relapsed or refractory [[follicular lymphoma|follicular lymphoma (FL)]] after three or more lines of systemic therapy. | ||
| + | *2022-10-14: Extension of indication to include treatment of adult patients with relapsed or refractory (r/r) [[diffuse large B-cell lymphoma|diffuse large B-cell lymphoma (DLBCL)]] and [[high-grade B-cell lymphoma|high-grade B-cell lymphoma (HGBL)]]. | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2019-02-13: Initial notice of compliance | ||
| + | *2022-09-29: Notice of compliance with conditions for the treatment of adult patients with relapsed or refractory grade [[Follicular lymphoma|1, 2 or 3a follicular lymphoma (FL)]] after two or more lines of systemic therapy. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2021-01-22: Initial approval | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' KTE-C19 | *'''Code name:''' KTE-C19 | ||
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<references/> | <references/> | ||
| − | [[Category: | + | [[Category:Anti-CD19 CAR T-cells]] |
| + | [[Category:Anti-CD3 cellular therapy]] | ||
| + | [[Category:Anti-CD19 cellular therapy]] | ||
| + | [[Category:Anti-CD28 cellular therapy]] | ||
| + | |||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| Line 33: | Line 51: | ||
[[Category:Transformed lymphoma medications]] | [[Category:Transformed lymphoma medications]] | ||
| + | [[Category:EMA approved in 2018]] | ||
[[Category:FDA approved in 2017]] | [[Category:FDA approved in 2017]] | ||
| + | [[Category:Health Canada approved in 2019]] | ||
| + | [[Category:PMDA approved in 2021]] | ||
[[Category:REMS program]] | [[Category:REMS program]] | ||
[[Category:Kite Pharma product]] | [[Category:Kite Pharma product]] | ||
Latest revision as of 19:27, 9 September 2023
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.
Toxicity management
Diseases for which it is established (work in progress)
- 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
- 2017-10-18: 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)
- 2021-03-05: 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)
- 2022-04-01: 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
- 2018-08-23: Initial marketing authorization as Yescarta. Yescarta is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. (Based on ZUMA-1)
- 2022-06-21: Extension of indication to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.
- 2022-10-14: Extension of indication to include treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).
History of changes in Health Canada indication
- 2019-02-13: Initial notice of compliance
- 2022-09-29: Notice of compliance with conditions for the treatment of adult patients with relapsed or refractory grade 1, 2 or 3a follicular lymphoma (FL) after two or more lines of systemic therapy.
History of changes in PMDA indication
- 2021-01-22: Initial approval
Also known as
- Code name: KTE-C19
- Generic names: Axicel, Axi-cel
- Brand name: Yescarta
References
Categories:
- Anti-CD19 CAR T-cells
- Anti-CD3 cellular therapy
- Anti-CD19 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
- Health Canada approved in 2019
- PMDA approved in 2021
- REMS program
- Kite Pharma product