Difference between revisions of "Tisagenlecleucel (Kymriah)"
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==Mechanism of action== | ==Mechanism of action== | ||
| − | + | From the [https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=736184 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. | |
| − | ==Diseases for which it is | + | ==Toxicity management== |
| + | *'''[http://www.kymriah-rems.com/ Link to REMS program]''' | ||
| + | |||
| + | ==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]] | ||
| + | *[[High-grade B-cell lymphoma]] | ||
*[[Transformed lymphoma]] | *[[Transformed lymphoma]] | ||
| + | |||
| + | ==Diseases for which it is used== | ||
| + | *[[Follicular lymphoma]] | ||
| + | |||
| + | ==Diseases for which it was used== | ||
| + | *[[Chronic lymphocytic leukemia - historical|Chronic lymphocytic leukemia]] | ||
| + | *[[Multiple myeloma - historical|Multiple myeloma]] | ||
==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 EMA indication== | ||
| + | *2017-08-30: Initial marketing authorisation | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2018-09-05: Initial notice of compliance | ||
| + | *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:''' | + | *'''Code name:''' CART19, CTL-019 |
| − | *'''Generic name:''' tisagenlecleucel-T | + | *'''Generic name:''' tisagenlecleucel-T, tisa-cel |
*'''Brand name:''' Kymriah | *'''Brand name:''' Kymriah | ||
| − | [[Category: | + | [[Category:Anti-CD19 CAR T-cells]] |
| + | [[Category:Anti-CD3 cellular therapy]] | ||
| + | [[Category:Anti-CD19 cellular therapy]] | ||
| + | [[Category:Anti-CD137 cellular therapy]] | ||
| + | |||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | |||
[[Category:B-cell acute lymphoblastic leukemia medications]] | [[Category:B-cell acute lymphoblastic leukemia medications]] | ||
[[Category:Diffuse large B-cell lymphoma medications]] | [[Category:Diffuse large B-cell lymphoma medications]] | ||
| + | [[Category:Follicular lymphoma medications]] | ||
| + | [[Category:High-grade B-cell lymphoma medications]] | ||
[[Category:Transformed lymphoma medications]] | [[Category:Transformed lymphoma medications]] | ||
| + | |||
| + | [[Category:Chronic lymphocytic leukemia medications (historic)]] | ||
| + | [[Category:Multiple myeloma medications (historic)]] | ||
[[Category:REMS program]] | [[Category:REMS program]] | ||
| − | [[Category: | + | [[Category:FDA approved in 2017]] |
| + | [[Category:EMA approved in 2017]] | ||
| + | [[Category:Health Canada approved in 2018]] | ||
Latest revision as of 23:25, 22 September 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 EMA indication
- 2017-08-30: Initial marketing authorisation
History of changes in Health Canada indication
- 2018-09-05: Initial notice of compliance
- 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, CTL-019
- Generic name: tisagenlecleucel-T, tisa-cel
- Brand name: Kymriah
Categories:
- Anti-CD19 CAR 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
- EMA approved in 2017
- Health Canada approved in 2018