Tisagenlecleucel (Kymriah)

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

Link to REMS program

Diseases for which it is established

Diseases for which it is used

Follicular lymphoma

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