ANZUTRESGENE AUTOLEUCEL
UNII RQA36PL3ZC

Substance Identification & Data

This profile provides standardized clinical and technical data for Anzutresgene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) RQA36PL3ZC.

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

RQA36PL3ZC

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

ANZUTRESGENE AUTOLEUCEL

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

NCI Thesaurus

C215289

National Cancer Institute reference terminology for clinical and research data.

INN ID

13480

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

OP-182

Identifier assigned by the United States Adopted Names Council.

Substance Type

Anzutresgene Autoleucel

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 Anzutresgene 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

Anzutresgene Autoleucel

Common Names & Synonyms

A genetically modified autologous T cell therapy expressing engineered TCR that recognizes cancer specific preferentially expressed antigen in melanoma (PRAME)

ANZUTRESGENE AUTOLEUCEL [USAN]

anzutresgene autoleucel [INN]

autologous CD4+/CD8+ enriched T lymphocytes transduced with a self-inactivating, non-replicating lentiviral vector encoding a T cell receptor (TCR) specific for the preferentially expressed antigen in melanoma (PRAME). The TCR transgene consists of a TCRα and a TCRβ chain separated by a self-cleaving ribosome skipping sequence derived from porcine teschovirus (P2A) under the control of a murine stem cell virus (MSCV) promoter and a Woodchuck hepatitis virus post-transcriptional response element (WPRE). The viral vector backbone also comprises a packaging signal ψ (psi), residual gag sequence, a Rev response element (RRE), a central polypurine tract/central termination sequence (cPPT/CTS) and is flanked by 5' and 3' long terminal repeats (LTRs) (The vector is pseudotyped with vesicular stomatitis virus G glycoprotein, The leukapheresis material is enriched for CD4+ and CD8+ T lymphocytes by positive immunoselection prior to activation with CD3 and CD28 agonists in growth media containing interleukin 7 (IL-7) and interleukin 15 (IL-15). The cells are then transduced with a lentiviral vector and expanded in growth media containing human AB serum, IL-7 and IL-15. The cell suspension consists of CD3+ T lymphocytes (≥90%) of which >20% of the CD3+CD8+ cells express the PRAME-specific TCR)

External Clinical & Regulatory Resources

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