ORVACABTAGENE AUTOLEUCEL
UNII K8RW1TW3EM

Substance Identification & Data

This profile provides standardized clinical and technical data for Orvacabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) K8RW1TW3EM.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number N/A and the RxNorm Concept ID (RxCUI) N/A. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code

K8RW1TW3EM

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

ORVACABTAGENE AUTOLEUCEL

Official standardized name for this substance within the FDA UNII nomenclature system.

NCI Thesaurus

C147523

National Cancer Institute reference terminology for clinical and research data.

INN ID

11274

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

GH-22

Identifier assigned by the United States Adopted Names Council.

Substance Type

structurallyDiverse

ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

ITIS TSN

180092

Taxonomic Serial Number for species identified in the Integrated Taxonomic Information System.

NCBI Taxonomy

9606

Unique numeric identifier used to specify biological species in the NCBI database.

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Orvacabtagene Autoleucel. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

FDA Official Name

ORVACABTAGENE AUTOLEUCEL

Common Names & Synonyms

JCARH125 CONSISTS OF HUMAN CULTURE EXPANDED GENETICALLY MODIFIED AUTOLOGOUS T CELLS FOR CELL-BASED GENE THERAPY. CD4+ CD8+ T CELLS ARE DERIVED FROM ISOLATED BLOOD OF THE PATIENT AND ARE TRANSDUCED WITH NON-REPLICATIVE SELF-INACTIVATING (SIN) LENTIVIRAL VECTOR ENCODING AN MSK54 ANTI-BCMA SINGLE CHAIN VARIABLE FRAGMENT (SCFV), LGG4-CH2-CH3 HINGE REGION, CD28/CD137 (4-1BB), CD3ZETA CHIMERIC ANTIGEN RECEPTOR (CAR) UNDER THE TRANSCRIPTIONAL CONTROL OF A HYBRID PROMOTER CONSISTING OF THE HUMAN TRANSLATION ELONGATION FACTOR 1 ALPHA (EF1ALPHA) PROMOTER AND THE R REGION PLUS PART OF THE U5 REGION FROM THE HUMAN T-CELL LEUKEMIA VIRUS (HTLV-1R). CELLS EXHIBIT ANTI-TUMORAL ACTIVITY IN PATIENTS WITH MULTIPLE MYELOMA

ORVACABTAGENE AUTOLEUCEL [INN]

ORVACABTAGENE AUTOLEUCEL [USAN]

ORVACABTAGENE AUTOLEUCEL [WHO-DD]