IMGT/mAb-DB card

Version: 2.0.4 (2023-04-14)

Citing IMGT/mAb-DB

Manso T., Kushwaha A., Abdollahi N., Duroux P., Giudicelli V. and Kossida S. Mechanisms of action of monoclonal antibodies in oncology integrated in IMGT/mAb-DB. Front Immunol., 14 (2023). DOI 10.3389/fimmu.2023.1129323

Poiron C., Wu Y., Ginestoux C., Ehrenmann, Duroux P. and Lefranc M.-P. IMGT/mAb-DB: the IMGT® database for therapeutic monoclonal antibodies. JOBIM 2010, Paper 13 (2010). Abstract

Cambon M., Cherouali K., Kushwaha A., Giudicelli V., Duroux P., Kossida S. and Lefranc M.-P. IMGT/mAb-DB and IMGT/2Dstructure-DB for IMGT standard definition of an antibody: from receptor to amino acid changes. JOBIM 2018, Poster 201 (2018). Abstract

IMGT/mAb-DB ID	44
INN	gemtuzumab
INN Number	8024
INN Prop. List	83 (2000)
INN Rec. List	45 (2001)
Common name	CMA-676 (ADC), hP67.6 (naked), CDP-771, WAY-CMA-676, hP67.6-calicheamicin (ADC),, MYLOTARG® (gemtuzumab ozogamicin)
Proprietary name
Species	Humanized
IMGT receptor type	IG
Format (legend)
Receptor identification	IgG4 - kappa
Radiolabelled / Conjugated / Fused	conjugated with N-acetyl-gamma calicheamicin
IMGT/2Dstructure-DB
IMGT/3Dstructure-DB
Specificity target name and species	CD33 (sialic acid binding Ig-like lectin 3, SIGLEC3, SIGLEC-3, gp67, p67) [Humanized]
Development Technology
Origin clone species	Mus musculus
Origin clone name	P67.6

Company	Pfizer (New York NY USA)
Expression system	NS0 mouse myeloma cells
Application	Therapeutic
Clinical domain	Hematology; Oncology
Mechanism of action
Clinical indication	Acute myeloid leukemia (AML) (CD33 positive)
Development status	Phase III
Regulatory agency status and year	FDA withdrawal (by Pfizer, on concerns about the product's safety and absence of clinical benefit in trials) June 01, 2010 FDA approval May 17, 2000

Clinical trials	102 studies found, 31 recruiting
Authority decisions	EMA: EMEA/37537/2008 (refusal of the marketing authorisation April 14, 2008)
External links	ATC: L01XC05 CenterWatch: 842 IUPHAR: Antibody 6775 IUPHAR: specificity 6775
IMGT citations	Information provided by Mitchell Reff, IDEC Pharmaceuticals. Marie-Paule Lefranc, IMGT (26/12/2005).
IMGT notes	Calicheamicin is a cytotoxin antitumor antibiotic, isolated from fermentation of a bacterium, Micromonospora echinospora, subsp. calichensis. Pfizer (New York NY USA) acquiered Wyeth Pharmaceuticals (Madison NJ USA) in 2010 Although gemtuzumab (#44, INN 8024 (83)(45)) has been used, conjugated with ozogamicin and marketed as MYLOTARG®, the INN for 'gemtuzumab ozogamicin' (#649, INN 10315 (115) (77)) has only been published in 2016 (L115). Updates for gemtuzumab ozogamicin posterior to 2016 are reported in the entry #649 gemtuzumab ozogamicin INN number 10315 (115).
Biosimilars

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