Table 2.
CAR-T products with approved market authorisation (by July 2021).
| Drug (company, tradename) | CAR construct development | CAR design, transduction | Current approved indications | Year of approval | Landmark study |
|---|---|---|---|---|---|
| Tisagenlecleucel* (Novartis, KYMRIAH®) | Children's Hospital of Philadelphia / University of Pennsylvania | CD19 – 4-1BB, Lentivirus | Third-line BCP-ALL <26 years | 2017 FDA 2018 EMA |
ELIANA (12) |
| Third-line PMBCL and DLBCL >18 years | 2018 FDA+EMA | JULIET (42) | |||
| Axicabtagene ciloleucel† (Kite, YESCARTA®) | National Cancer Institute / Memorial Sloan Kettering Cancer Centre | CD19 – CD28, Retrovirus | Third-line PMBCL and DLBCL >18 years | 2017 FDA 2018 EMA |
ZUMA-1 (43, 44) |
| Third-line follicular lymphoma >18 years | 2021 FDA | ZUMA-5 (45) | |||
| Brexucabtagene autoleucel (Kite, TECARTUS™) | National Cancer Institute / Memorial Sloan Kettering Cancer Centre | CD19 – CD28, Retrovirus, T-cell enrichment | R/R MCL | 2020 FDA 2021 EMA |
ZUMA-2 (46) |
| Lisocabtagene maraleucel (Juno, Breyanzi®) | Seattle group | CD19 – 4-1BB, Lentivirus, CD4/CD8 1:1 | Third-line PMBCL, DLBCL, and follicular lymphoma >18 years | 2020 EMA 2021 FDA |
TRANSCEND (47) |
| Idecabtagene vicleucel (Bluebird/BMS, ABECMA®) | Bluebird | BCMA – 4-1BB, Lentivirus | Fourth-line multiple myeloma | 2021 EMA+FDA | KarMMa (48, 49) |
*
Approved for paediatric/AYA BCP-ALL.
†
Currently under investigation in clinical trials for paediatric/AYA BCP-ALL.
AYA, adolescents and young adults; BCP-ALL, B-cell precursor acute lymphoblastic leukaemia; BCMA, B-cell maturation antigen; CAR-T, chimeric antigen receptor T-cell therapy; DLBCL, diffuse large B-cell lymphoma; EMA, European Medicines Agency; FDA, Food and Drug Administration (US); PMBCL, primary mediastinal large B-cell lymphoma; R/R, relapsed or refractory.