Difference between revisions of "Tisagenlecleucel (Kymriah)"
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*[[Diffuse large B-cell lymphoma]] | *[[Diffuse large B-cell lymphoma]] | ||
*[[Transformed lymphoma]] | *[[Transformed lymphoma]] | ||
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| + | ==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== | ||
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[[Category:Diffuse large B-cell lymphoma medications]] | [[Category:Diffuse large B-cell lymphoma medications]] | ||
[[Category:Transformed lymphoma medications]] | [[Category:Transformed lymphoma medications]] | ||
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| + | [[Category:Chronic lymphocytic leukemia medications (historic)]] | ||
| + | [[Category:Multiple myeloma medications (historic)]] | ||
[[Category:REMS program]] | [[Category:REMS program]] | ||
[[Category:FDA approved in 2017]] | [[Category:FDA approved in 2017]] | ||
Revision as of 01:50, 29 April 2022
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
Diseases for which it was 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