Difference between revisions of "Axicabtagene ciloleucel (Yescarta)"
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Warner-admin (talk | contribs) m (Text replacement - "==Diseases for which it is established==" to "==Diseases for which it is established ''(work in progress)''==") |
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==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== | ==History of changes in EMA indication== | ||
− | * | + | *2018-08-23: Initial marketing authorization as Yescarta. |
+ | ==History of changes in Health Canada indication== | ||
+ | *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. | ||
==Also known as== | ==Also known as== |
Revision as of 12:30, 31 March 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.
History of changes in Health Canada indication
- 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.
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