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. 2009 May;157(2):220–233. doi: 10.1111/j.1476-5381.2009.00190.x

Table 1.

Monoclonal antibodies approved for therapeutic use

Generic name Trade name Antibody format Antigen Approved indication 13FDA approval 13EMEA approval
Muromomab Orthoclone Murine, IgG2a CD3 Allograft rejection in allogeneic renal transplantation 86/06/19 NA
Abciximab1 ReoPro Chimeric, IgG1 GPIIb/IIIa r Maintenance of coronary patency 94/12/22 NA
Rituximab2 Mabthera Chimeric, IgG1 CD20 CD20-positive B-cell non-Hodgkin's lymphoma 97/11/26 98/06/02
Daclizumab Zenapax Humanized, IgG1 CD25 (Il2r) Allograft rejection 97/12/10 99/02/26
Basiliximab Simulect Chimeric, IgG1 CD25 (Il2r) Allograft rejection 98/05/12 98/10/09
Palivizumab Synagis Humanized, IgG1 Protein F Respiratory syncytial virus (RSV inhibitor) in children 98/06/19 99/08/13
Infliximab Remicade Chimeric, IgG1 TNFα Crohn's disease and rheumatoid arthritis 98/08/24 99/08/13
Trastuzumab Herceptin Humanized, IgG1 HER2/Neu Metastatic breast cancer 98/09/25 00/08/28
Etanercept3 Enbrel huFcγ1/TNFr TNFα and β Autoimmune diseases such as ankylosing spondylitis 98/11/02 00/02/03
Gemtuzumab4 Mylotarg Humanized, IgG4 CD33 CD33-positive acute myeloid leukemia 00/05/17 NA
Alemtuzumab5 Mabcampath Humanized, IgG1 CD52 B-cell chronic lymphocytic leukemia 01/05/07 01/07/06
Ibritomomab6 Zevalin 90Y Mouse, IgG1 CD20 B-cell non-Hodgkin's lymphoma 02/02/19 04/01/16
Adalimumab7 Trudexa Human, IgG1 (PD) TNFα Crohn's disease and rheumatoid arthritis 02/12/31 03/09/01
Alefacept3 Amevive huFcγ1/LFA-3 CD2 Chronic plaque psoriasis 03/01/30 NA
Omalizumab Xolair Humanized, IgG1 IgE Treatment of asthma 03/06/20 05/10/25
Tositumomab68 Bexxar 131I Murine, IgG2a CD20 CD20-positive B-cell non-Hodgkin's lymphoma 03/06/27 NA
Efalizumab Raptiva Humanized, IgG1 CD11a Moderate to severe plaque psoriasis 03/10/27 04/09/20
Cetuximab Erbitux Chimeric, IgG1 EGFR Metastatic colorectal and head and neck carcinoma 04/02/12 04/06/29
Bevacizumab Avastin Humanized, IgG1 VEGF-A Metastatic colorectal and non-small cell lung carcinoma 04/02/26 05/01/12
Natalizumab9 Tysabri Humanized, IgG4 Integrin-α4 Multiple sclerosis 04/11/23 06/06/27
Ranibizumab Lucentis Humanized, IgG1 VEGF-A Wet-type age-related macular degeneration 06/06/30 07/01/22
Panitumumab10 Vectibis Human, IgG2 EGFR Metastatic colorectal carcinoma 06/09/27 07/12/19
Eculizumab11 Soliris Humanized, IgG2/4 C5 Paroxysmal nocturnal haemoglobinuria 07/03/16 07/06/20
Certolizumab12 Cimzia Humanized, IgG1 TNFα Crohn's disease 08/04/18 NA
1

Abciximab is a Fab fragment.

2

Rituximab is commercialized under the trade name Rituxan in USA.

3

These molecules are fusions between the IgG1 Fc portion and a receptor. On 2 May 2008, the FDA placed a black box warning on Etanercept due to a number of serious infections associated with the drug.

4

Gemtuzumab ‘ozogamicine’ is coupled to calicheamicin, an anti-tumoural antibiotic.

5

Alemtuzumab is commercialized under the trade name Campath in USA.

6

Ibritomomab ‘tiuxetan’ and Tositumomab are coupled to radioisotopes.

7

Adalimumab is commercialized under the trade name Humira in USA.

8

All approved antibodies have a κ light chain except Tositumomab that has a γ light chain.

9

Natalizumab was voluntarily withdrawn from the market in February 2005. On 5 June 2006, FDA approved a special restricted distribution programme.

10

Panitumumab is the first human antibody obtained from humanized mice.

11

Eculizumab contains a CH1 domain and hinge from IgG2, and CH2–CH3 domains from IgG4.

12

Certolizumab pegol is a PEGylated humanized Fab fragment.

13

Year/month/day; NA, not approved in Europe.

EGFR, epidermal growth factor receptor; EMEA, European Medicines Agency; FDA, US Food and Drug Administration; HER, human epidermal growth factor receptor; TNF, tumour necrosis factor; VEGF, vascular endothelial growth factor.