Difference between revisions of "Tisagenlecleucel (Kymriah)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *8/30/2017: Granted [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm574154.htm FDA regular approval] | + | *8/30/2017: 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)'' |
| − | *5/1/2018: FDA approval expanded | + | *5/1/2018: 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)'' |
==Also known as== | ==Also known as== | ||
Revision as of 01:15, 26 May 2021
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.
Link to REMS program
Diseases for which it is used
History of changes in FDA indication
- 8/30/2017: 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)
- 5/1/2018: 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)
Also known as
- Code name: CART19, CTL019
- Generic name: tisagenlecleucel-T
- Brand name: Kymriah