Table 2.
Therapeutic monoclonal antibodies approved or in review in the European Union or the USA
| Name | Trade name | Type | Indication first approved | First EU (US) approval year |
|---|---|---|---|---|
| Muromonab-CD3 | Orthoclone Okt3 | Anti-CD3; Murine IgG2a | Reversal of kidney transplant rejection | 1986a(1986#2010@) |
| Abciximab | Reopro | Anti-GPIIb/IIIa; Chimeric IgG1 Fab | Prevention of blood clots in angioplasty | 1995a (1994) |
| Rituximab | MabThera, Rituxan | Anti-CD20; Chimeric IgG1 | Non-Hodgkin’s lymphoma | 1998 (1997) |
| Basiliximab | Simulect | Anti-IL2R; Chimeric IgG1 | Prevention of kidney transplant rejection | 1998 (1998) |
| Daclizumab | Zenapax | Anti-IL2R; Humanized IgG1 | Prevention of kidney transplant rejection | 1999 (1997); #2009 |
| Palivizumab | Synagis | Anti-RSV; Humanized IgG1 | Prevention of respiratory syncytial virus infection | 1999 (1998) |
| Infliximab | Remicade | Anti-TNF; Chimeric IgG1 | Crohn’s disease | 1999 (1998) |
| Trastuzumab | Herceptin | Anti-HER2; Humanized IgG1 | Breast cancer | 2000 (1998) |
| Gemtuzumab ozogamicin | Mylotarg | Anti-CD33; Humanized IgG4 | Acute myeloid leukemia | NA (2000#2010) |
| Alemtuzumab | MabCampath, Campath-1H | Anti-CD52; Humanized IgG1 | Chronic myeloid leukemia | 2001 (2001) |
| Adalimumab | Humira | Anti-TNF; Human IgG1 | Rheumatoid arthritis | 2003 (2002) |
| Tositumomab + 131I-Tositumomab | Bexxar | Anti-CD20; Murine IgG2a | Non-Hodgkin lymphoma | NA (2003) |
| Efalizumab | Raptiva | Anti-CD11a; humanized IgG1 | Psoriasis | 2004 (2003); #2009 |
| Cetuximab | Erbitux | Anti-EGFR; chimeric IgG1 | Colorectal cancer | 2004 (2004) |
| Ibritumomab tiuxetan | Zevalin | Anti-CD20; murine IgG1 | Non-Hodgkin’s lymphoma | 2004 (2002) |
| Omalizumab | Xolair | Anti-IgE; humanized IgG1 | Asthma | 2005 (2003) |
| Bevacizumab | Avastin | Anti-VEGF; humanized IgG1 | Colorectal cancer | 2005 (2004) |
| Natalizumab | Tysabri | Anti-a4 integrin; humanized IgG4 | Multiple sclerosis | 2006 (2004) |
| Ranibizumab | Lucentis | Anti-VEGF; humanized IgG1 Fab | Macular degeneration | 2007 (2006) |
| Panitumumab | Vectibix | Anti-EGFR; human IgG2 | Colorectal cancer | 2007 (2006) |
| Eculizumab | Soliris | Anti-C5; humanized IgG2/4 | Paroxysmal nocturnal hemoglobinuria | 2007 (2007) |
| Certolizumab pegol | Cimzia | Anti-TNF; humanized Fab, pegylated | Crohn disease | 2009 (2008) |
| Golimumab | Simponi | Anti-TNF; human IgG1 | Rheumatoid and psoriatic arthritis, ankylosing spondylitis | 2009 (2009) |
| Canakinumab | Ilaris | Anti-IL1b; human IgG1 | Muckle-Wells syndrome | 2009 (2009) |
| Catumaxomab | Removab | Anti-EPCAM/CD3;rat/mouse bispecific mAb | Malignant ascites | 2009 (NA) |
| Ustekinumab | Stelara | Anti-IL12/23; human IgG1 | Psoriasis | 2009 (2009) |
| Tocilizumab | RoActemra, Actemra | Anti-IL6R; humanized IgG1 | Rheumatoid arthritis | 2009 (2010) |
| Ofatumumab | Arzerra | Anti-CD20; human IgG1 | Chronic lymphocytic leukemia | 2010 (2009) |
| Denosumab | Prolia | Anti-RANK-L; human IgG2 | Bone loss | 2010 (2010) |
| Belimumab | Benlysta | Anti-BLyS; human IgG1 | Systemic lupus erythematosus | (2011) |
| Raxibacumab | (Pending) | Anti-B. anthrasis PA; human IgG1 | Anthrax infection | NA (in review) |
| Ipilimumab | Yervoy | Anti-CTLA-4; human IgG1 | Metastatic melanoma | (2011) |
| Brentuximab vedotin | (Pending) | Anti-CD30; chimeric IgG1; immunoconjugate | Hodgkin lymphoma, systemic ALCL | NA (application submitted) |
Information current as of July 2011. Updated and modified from Janice M. Reichert, Editor-in-Chief, mAbs
Country-specific approval; approved under concertation procedure; #Voluntarily withdrawn from the market. @Supplies are exhausted in 2010. BLyS B lymphocyte stimulator, C5 complement 5, CD cluster of differentiation, CTLA-4 cytotoxic T lymphocyte antigen 4, EGFR epidermal growth factor receptor, EPCAM epithelial cell adhesion molecule, GP glycoprotein, IL interleukin, NA not approved, PA protective antigen, RANK-L receptor activator of NFkb ligand, RSV respiratory syncytial virus, TNF tumor necrosis factor, VEGF vascular endothelial growth factor. Not included here are polyclonal antibodies against infectious diseases and toxins