Difference between revisions of "Tisagenlecleucel (Kymriah)"
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*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)'' | *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 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)'' | *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)'' | ||
− | *5/27/2022: Granted accelerated approval for adult patients with relapsed or refractory [[follicular lymphoma|follicular lymphoma (FL)]] after two or more lines of systemic therapy. | + | *5/27/2022: 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)'' |
==Also known as== | ==Also known as== |
Revision as of 14:38, 31 May 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.
Toxicity management
Diseases for which it is established (work in progress)
- B-cell acute lymphoblastic leukemia
- Diffuse large B-cell lymphoma
- Follicular lymphoma
- High-grade B-cell lymphoma
- Transformed lymphoma
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)
- 5/27/2022: Granted accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. (Based on ELARA)
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