AXICABTAGENE CILOLEUCEL

U.S. Department of Health & Human Services Divider Arrow

National Institutes of Health Divider Arrow

NCATS

US Approved Rx (2017)

First approved in 2017

US Approved Rx (2017)

First approved in 2017

Approval Year

Substance Class	Structurally Diverse Created by `admin` on `Tue Apr 01 20:40:31 GMT 2025` Edited by `admin` on `Tue Apr 01 20:40:31 GMT 2025`
Source Materials Class	ORGANISM
Source Materials Type	AUTOLOGOUS HUMAN
Source Materials State	LIVE
Source Materials Parent	`G0T704E6Z3` HOMO SAPIENS WHOLE
Part	blood
Fraction Material Type	cell
Fraction Name	cd4 and cd8 positive
Record UNII	U2I8T43Y7R
Record Status	`Validated (UNII)`
Record Version

Download

Name

Type

Language

AXICABTAGENE CILOLEUCEL

Official Name

English

KTE-C19

Preferred Name

English

Axicabtagene ciloleucel [WHO-DD]

Common Name

English

axicabtagene ciloleucel [INN]

Common Name

English

YESCARTA

Brand Name

English

AUTOLOGOUS T CELLS TRANSDUCED WITH RETROVIRAL VECTOR ENCODING AN ANTI-CD-19 CD28/CD3-ZETA CHIMERIC ANTIGEN RECEPTOR

Common Name

English

AXICABTAGENE CILOLEUCEL [USAN]

Common Name

English

Cells are derived from isolated blood of the patient and are transduced with non-replicative retroviral vector encoding the FMC63 anti-CD19 single chain variable fragment (scFv) CD28/CD3zeta chimeric antigen receptor (FMC63-28Z CAR). Cells exhibit anti-t

Common Name

English

Axicabtagene ciloleucel (autologous CD19 CAR transduced PBL)

Common Name

English

Classification Tree Code System Code

NCI_THESAURUS

C129826

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

FDA ORPHAN DRUG

515615

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

FDA ORPHAN DRUG

735920

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

NCI_THESAURUS

C28681

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

FDA ORPHAN DRUG

423914

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

FDA ORPHAN DRUG

515915

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

FDA ORPHAN DRUG

740320

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

NCI_THESAURUS

C137999

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

EU-Orphan Drug

EU/3/15/1553

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

Code System Code Type Description

USAN

DE-33

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

PRIMARY

DRUG BANK

DB13915

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

PRIMARY

RXCUI

1987398

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

PRIMARY

DAILYMED

U2I8T43Y7R

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

PRIMARY

NCI_THESAURUS

C120309

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

PRIMARY

SMS_ID

100000174423

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

PRIMARY

INN

10518

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

PRIMARY

FDA UNII

U2I8T43Y7R

Created by admin on Tue Apr 01 20:40:31 GMT 2025 , Edited by admin on Tue Apr 01 20:40:31 GMT 2025

PRIMARY

Related Record Type Details


					U2I8T43Y7R

AXICABTAGENE CILOLEUCEL

ACTIVE MOIETY

Amount:

Agent Modifications

Modification Process	Modification Role	Modification Type	Amount	Fragment Name	Fragment ID
CULTURE	ACTIVATOR	IMMUNOLOGICAL		MUROMONAB-CD3	JGA39ICE2V
CULTURE	GROWTH FACTOR	BIOLOGICAL		ALDESLEUKIN	M89N0Q7EQR
TRANSDUCTION	ANTIGEN EXPRESSION	TRANSDUCING VECTOR		UNSPECIFIED SUBSTANCE	0f2235db

Structural Modifications

Modification Type	Location Site	Location Type	Residue Modified	Extent	Fragment Name	Fragment Approval
MOIETY					ANTI-CD-19 CD28/CD3-ZETA CHIMERIC ANTIGEN RECEPTOR (KTE-CD19)	V248BS56D0