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Sources for CAR T cell page:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9175669/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8764468/

Europe: European Medicines Agency

https://www.ema.europa.eu/en/medicines/human/EPAR/yescarta#assessment-history-section

https://www.ema.europa.eu/en/medicines/human/EPAR/kymriah

Japan: The Pharmaceuticals and Medical Devices Agency

India: The Central Drugs Standard Control Organization _______________________________________________

CAR T Cell Therapies with Regulatory Approval

**CAR T Cell Therapies with Regulatory Approval**
CAR T cell (Brand name)	Company	Approval date	Approval Agency	Target	Antigen recognition domain	Intracellular signaling domain	Indication (Targeted disease / Line of Therapy)	Agency Product Number	Drug Label
tisagenlecleucel (Kymriah)	Novartis	08/30/2017 ^[1] 08/22/2018 ^[2] 05/15/2019 ^[3]	FDA EMA MHLW	CD19	scFV	41BB - CD3ζ	B-cell precursor ALL (Third Line)^[1] ^[2] ^[3] Diffuse large B-cell lymphoma (Third Line)^[4] ^[2] ^[3] Follicular Lymphoma (Third Line)^[5] ^[6]	FDA:125646 EMA:004090	FDA Link EMA Link
axicabtagene ciloleucel (Yescarta)	Kite Pharma / Gilead	10/18/2017 ^[7] 08/27/2018 ^[8] 06/23/2021 ^[9] 12/22/2022 ^[10]	FDA EMA NMPA MHLW	CD19	scFV	CD28 - CD3ζ	Diffuse large B-cell lymphoma (Second Line)^[11] ^[8] ^[12] ^[9] ^[10] Follicular lymphoma (Third Line) ^[13] ^[14] ^[9] ^[10] Primary mediastinal large B-cell lymphoma (Third Line) ^[8] ^[9] ^[10]	FDA:125643 EMA:004480	FDA Link EMA Link
brexucabtagene autoleucel (Tecartus)	Kite Pharma / Gilead	07/24/2020 ^[15] 12/14/2020 ^[16]	FDA EMA	CD19	scFV	CD28 - CD3ζ	Mantle cell lymphoma (Third Line) ^[17] ^[16] B-cell precursor ALL (Third Line)^[17] ^[16]	FDA:125703 EMA:005102	FDA Link EMA Link
lisocabtagene maraleucel (Breyanzi)	Juno Therapeutics / BMS	02/05/2021^[18] 04/04/2022 ^[19] 12/20/2022 ^[20]	FDA EMA MHLW	CD19	scFV	41BB - CD3ζ	Diffuse large B-cell lymphoma (Second Line)^[21] ^[19] ^[20]	FDA: 25714 EMA:004731	FDA Link EMA Link
idecabtagene vicleucel (Abecma)	Bluebird Bio / BMS	03/26/2021 ^[22] 08/18/2021 ^[23]	FDA EMA	BCMA	scFV	41BB - CD3ζ	Multiple myeloma (Fifth Line)^[22] (Fourth Line) ^[23]	FDA:125736 EMA:004662	FDA Link EMA Link
ciltacabtagene autoleucel (Carvykti)	Janssen / J&J	02/28/2022 ^[24] 05/25/2022 ^[25]	FDA EMA	BCMA	VHH	41BB - CD3ζ	Multiple myeloma (Fifth Line)^[24] (Fourth Line)^[25]	FDA:125746 EMA:005095	FDA Link EMA Link

^ ^a ^b "Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah(TM) (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice". www.novartis.com. 2017-08-30.
^ ^a ^b ^c "Novartis receives European Commission approval of its CAR-T cell therapy, Kymriah® (tisagenlecleucel)". www.novartis.com. Retrieved 2023-11-18.
^ ^a ^b ^c "Novartis gets approval to sell Kymriah in Japan for $306,000". www.reuters.com. 2019-05-15.
^ "KYMRIAH (tisagenlecleucel)". US Food and Drug Administration. 2019-04-05.
^ "FDA approves Novartis Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma". Novartis. Retrieved 2022-06-05.
^ "Novartis Kymriah® receives EC approval as first CAR-T cell therapy for adults with relapsed or refractory follicular lymphoma". www.novartis.com. Retrieved 2023-11-18.
^ Center for Biologics Evaluation and Research (2017-10-18). "FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma". FDA.
^ ^a ^b ^c "Yescarta® (Axicabtagene Ciloleucel) Receives European Marketing Authorization for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy". www.gilead.com. Retrieved 2023-11-18.
^ ^a ^b ^c ^d "Kite Joint Venture - Fosun Kite - Gains the First CAR T-cell Therapy Approval in China". www.gilead.com. Retrieved 2023-11-13.
^ ^a ^b ^c ^d "Yescarta® Now Approved in Japan for Initial Treatment of Relapsed/Refractory Large B-Cell Lymphoma". www.gilead.com. 2022-12-22.
^ Center for Biologics Evaluation and Research (2020-05-28). "YESCARTA (axicabtagene ciloleucel)". FDA.
^ "Kite's CAR T-cell Therapy Yescarta® First in Europe to Receive Positive CHMP Opinion for Use in Second-line Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma". www.gilead.com. Retrieved 2023-11-18.
^ "U.S. FDA Approves Yescarta® for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy". www.gilead.com. Retrieved 2021-03-15.
^ "Kite's CAR T-cell Therapy Yescarta® Granted European Marketing Authorization for the Treatment of Relapsed or Refractory Follicular Lymphoma". www.gilead.com. Retrieved 2023-11-18.
^ Center for Biologics Evaluation and Research (2021-03-04). "TECARTUS (brexucabtagene autoleucel)". FDA.
^ ^a ^b ^c European Medicines Agency (2023-01-30). "TECARTUS (brexucabtagene autoleucel)". EMA.
^ ^a ^b Center for Biologics Evaluation and Research (2021-03-04). "TECARTUS (brexucabtagene autoleucel)". FDA.
^ "U.S. Food and Drug Administration Approves Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel), a New CAR T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma". news.bms.com. Retrieved 2023-11-21.
^ ^a ^b European Medicines Agency (2023-11-10). "Breyanzi". EMA.
^ ^a ^b "CAR T Cell Therapy Breyanzi® Approved as Relapsed or Refractory Large B-cell Lymphoma Second-Line Therapy in Japan". new.bms.com.
^ Center for Biologics Evaluation and Research (2022-06-24). "FDA D.I.S.C.O. Burst Edition: FDA approval of Breyanzi (lisocabtagene maraleucel) for second-line treatment of large B-cell lymphoma". FDA.
^ ^a ^b Center for Biologics Evaluation and Research (2021-03-27). "ABECMA (idecabtagene vicleucel)". FDA.
^ ^a ^b European Medicines Agency (2023-07-27). "Abecma". EMA.
^ ^a ^b Center for Biologics Evaluation and Research (2022-03-21). "CARVYKTI". FDA.
^ ^a ^b European Medicines Agency (2023-07-27). "Carvykti". EMA.

[:8-1] "Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah(TM) (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice". www.novartis.com. 2017-08-30.

[kymriaheu-2] "Novartis receives European Commission approval of its CAR-T cell therapy, Kymriah® (tisagenlecleucel)". www.novartis.com. Retrieved 2023-11-18.

[Kymriah_Jap-3] "Novartis gets approval to sell Kymriah in Japan for $306,000". www.reuters.com. 2019-05-15.

[:7-4] "KYMRIAH (tisagenlecleucel)". US Food and Drug Administration. 2019-04-05.

[5] "FDA approves Novartis Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma". Novartis. Retrieved 2022-06-05.

[6] "Novartis Kymriah® receives EC approval as first CAR-T cell therapy for adults with relapsed or refractory follicular lymphoma". www.novartis.com. Retrieved 2023-11-18.

[yescarta2017-7] Center for Biologics Evaluation and Research (2017-10-18). "FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma". FDA.

[yescarta_EMA-8] "Yescarta® (Axicabtagene Ciloleucel) Receives European Marketing Authorization for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy". www.gilead.com. Retrieved 2023-11-18.

[yescarta_NMPA-9] "Kite Joint Venture - Fosun Kite - Gains the First CAR T-cell Therapy Approval in China". www.gilead.com. Retrieved 2023-11-13.

[Yescarta_Jap-10] "Yescarta® Now Approved in Japan for Initial Treatment of Relapsed/Refractory Large B-Cell Lymphoma". www.gilead.com. 2022-12-22.

[11] Center for Biologics Evaluation and Research (2020-05-28). "YESCARTA (axicabtagene ciloleucel)". FDA.

[yescarta_EMA_2nd_line-12] "Kite's CAR T-cell Therapy Yescarta® First in Europe to Receive Positive CHMP Opinion for Use in Second-line Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma". www.gilead.com. Retrieved 2023-11-18.

[13] "U.S. FDA Approves Yescarta® for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy". www.gilead.com. Retrieved 2021-03-15.

[14] "Kite's CAR T-cell Therapy Yescarta® Granted European Marketing Authorization for the Treatment of Relapsed or Refractory Follicular Lymphoma". www.gilead.com. Retrieved 2023-11-18.

[15] Center for Biologics Evaluation and Research (2021-03-04). "TECARTUS (brexucabtagene autoleucel)". FDA.

[Tecartus_EU-16] European Medicines Agency (2023-01-30). "TECARTUS (brexucabtagene autoleucel)". EMA.

[Tecartus_FDA-17] Center for Biologics Evaluation and Research (2021-03-04). "TECARTUS (brexucabtagene autoleucel)". FDA.

[18] "U.S. Food and Drug Administration Approves Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel), a New CAR T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma". news.bms.com. Retrieved 2023-11-21.

[Breyanzi_EMA-19] European Medicines Agency (2023-11-10). "Breyanzi". EMA.

[Breyanzi_Jap-20] "CAR T Cell Therapy Breyanzi® Approved as Relapsed or Refractory Large B-cell Lymphoma Second-Line Therapy in Japan". new.bms.com.

[21] Center for Biologics Evaluation and Research (2022-06-24). "FDA D.I.S.C.O. Burst Edition: FDA approval of Breyanzi (lisocabtagene maraleucel) for second-line treatment of large B-cell lymphoma". FDA.

[Abecma_FDA-22] Center for Biologics Evaluation and Research (2021-03-27). "ABECMA (idecabtagene vicleucel)". FDA.

[Abecma_EMA-23] European Medicines Agency (2023-07-27). "Abecma". EMA.

[Carvykti_FDA-24] Center for Biologics Evaluation and Research (2022-03-21). "CARVYKTI". FDA.

[Carvykti_EMA-25] European Medicines Agency (2023-07-27). "Carvykti". EMA.

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