Difference between revisions of "Tisagenlecleucel (Kymriah)"
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*'''[http://www.kymriah-rems.com/ Link to REMS program]''' | *'''[http://www.kymriah-rems.com/ Link to REMS program]''' | ||
− | ==Diseases for which it is established | + | ==Diseases for which it is established== |
*[[B-cell acute lymphoblastic leukemia]] | *[[B-cell acute lymphoblastic leukemia]] | ||
*[[Diffuse large B-cell lymphoma]] | *[[Diffuse large B-cell lymphoma]] | ||
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
− | * | + | *2017-08-30: Granted [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm574154.htm FDA regular approval] for the treatment of patients up to age 25 years with [[B-cell acute lymphoblastic leukemia|B-cell precursor acute lymphoblastic leukemia (ALL)]] that is refractory or in second or later relapse. ''(Based on ELIANA)'' |
− | * | + | *2018-05-01: FDA approval expanded for 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]], [[high-grade B-cell lymphoma]] and [[Transformed lymphoma|DLBCL arising from follicular lymphoma]]. ''(Based on JULIET)'' |
− | * | + | *2022-05-27: 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 ELARA)'' |
− | + | ==History of changes in Health Canada indication== | |
+ | *2022-12-19: Notice of compliance with conditions for adult patients with relapsed or refractory [[Follicular lymphoma|1, 2, 3a follicular lymphoma (FL)]] after two or more lines of systemic therapy. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' CART19, CTL019 | *'''Code name:''' CART19, CTL019 |
Revision as of 11:11, 30 March 2023
Mechanism of action
From the NCI Drug Dictionary: Autologous T lymphocytes transduced with a modified lentiviral vector expressing a chimeric antigen receptor (CAR) consisting of an anti-CD19 scFv (single chain variable fragment) and the zeta chain of the TCR/CD3 complex (CD3-zeta), coupled to the signaling domain of 4-1BB (CD137), with potential immunomodulating and antineoplastic activities. Upon transfusion, tisagenlecleucel direct the T lymphocytes to CD19-expressing tumor cells, thereby inducing a selective toxicity in CD19-expressing tumor cells.
Toxicity management
Diseases for which it is established
- B-cell acute lymphoblastic leukemia
- Diffuse large B-cell lymphoma
- High-grade B-cell lymphoma
- Transformed lymphoma
Diseases for which it is used
Diseases for which it was used
History of changes in FDA indication
- 2017-08-30: Granted FDA regular approval for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. (Based on ELIANA)
- 2018-05-01: FDA approval expanded for 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, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma. (Based on JULIET)
- 2022-05-27: Granted accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. (Based on ELARA)
History of changes in Health Canada indication
- 2022-12-19: Notice of compliance with conditions for adult patients with relapsed or refractory 1, 2, 3a follicular lymphoma (FL) after two or more lines of systemic therapy.
Also known as
- Code name: CART19, CTL019
- Generic name: tisagenlecleucel-T
- Brand name: Kymriah
Categories:
- Chimeric antigen receptor T-cells
- Anti-CD3 cellular therapy
- Anti-CD19 cellular therapy
- Anti-CD137 cellular therapy
- Intravenous medications
- B-cell acute lymphoblastic leukemia medications
- Diffuse large B-cell lymphoma medications
- Follicular lymphoma medications
- High-grade B-cell lymphoma medications
- Transformed lymphoma medications
- Chronic lymphocytic leukemia medications (historic)
- Multiple myeloma medications (historic)
- REMS program
- FDA approved in 2017