Table 1. Therapeutic monoclonal antibodies approved in the US
|
Generic name |
Trade name |
Type |
Indication first approved |
FDA approval year |
|
Muromonab-CD3 |
Orthoclone Okt3 |
Murine IgG2a |
Reversal of kidney transplant rejection |
1986 |
|
Abciximab |
Reopro |
Chimeric IgG1 Fab |
Prevention of blood clots in angioplasty |
1994 |
|
Rituximab |
Rituxan |
Chimeric IgG1 |
Non-Hodgkin lymphoma |
1997 |
|
Daclizumab |
Zenapax |
Humanized IgG1 |
Prevention of kidney transplant rejection |
1997 |
|
Basiliximab |
Simulect |
Chimeric IgG1 |
Prevention of kidney transplant rejection |
1998 |
|
Palivizumab |
Synagis |
Humanized IgG1 |
Prevention of respiratory syncytial virus infection |
1998 |
|
Infliximab |
Remicade |
Chimeric IgG1 |
Crohn disease |
1998 |
|
Trastuzumab |
Herceptin |
Humanized IgG1 |
Breast cancer |
1998 |
|
Gemtuzumab ozogamicin |
Mylotarg |
Humanized IgG4 |
Acute myeloid leukemia |
2000 |
|
Alemtuzumab |
Campath-1H |
Humanized IgG1 |
Chronic myeloid leukemia |
2001 |
|
Ibritumomab tiuxetan |
Zevalin |
Murine IgG1 |
Non-Hodgkin lymphoma |
2002 |
|
Adalimumab |
Humira |
Human IgG1 |
Rheumatoid arthritis |
2002 |
|
Omalizumab |
Xolair |
Humanized IgG1 |
Asthma |
2003 |
|
Tositumomab-I131 |
Bexxar |
Murine IgG2a |
Non-Hodgkin lymphoma |
2003 |
|
Efalizumab |
Raptiva |
Humanized IgG1 |
Psoriasis |
2003* |
|
Cetuximab |
Erbitux |
Chimeric IgG1 |
Colorectal cancer |
2003 |
|
Bevacizumab |
Avastin |
Humanized IgG1 |
Colorectal cancer |
2004 |
|
Natalizumab |
Tysabri |
Humanized IgG4 |
Multiple sclerosis |
2004 |
|
Ranibizumab |
Lucentis |
Humanized IgG1 Fab |
Macular degeneration |
2006 |
|
Panitumumab |
Vectibix |
Human IgG2 |
Colorectal cancer |
2006 |
|
Eculizumab |
Soliris |
Humanized IgG2/4 |
Paroxysmal nocturnal hemoglobinuria |
2007 |
Certolizumab |
Cimzia | Humanized Fab | Crohn disease | 2008 |
| Golimumab | Simponi | Human IgG1 | Rheumatoid and psoriatic arthritis, ankylosing spondylitis | 2009 |
*Voluntarily withdrawn from US market in April 2009
Source: Tufts Center for the Study of Drug Development