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. | 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. | ||
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| + | ==Toxicity management== | ||
| + | *'''[http://www.kymriah-rems.com/ Link to REMS program]''' | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
Revision as of 01:17, 20 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 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
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
- Transformed lymphoma medications
- Chronic lymphocytic leukemia medications (historic)
- Multiple myeloma medications (historic)
- REMS program
- FDA approved in 2017