TABLE 1.
INN | Brand name(s) | Target; format | Indication(s) first approved or reviewed | 1st U.S. approval yr |
---|---|---|---|---|
Oncology | ||||
Daratumumab | Darzalex | CD38; human IgG1 | Multiple myeloma | 2015 |
Elotuzumab | Empliciti | SLAMF7; humanized IgG1 | Multiple myeloma | 2015 |
Nivolumab | Opdivo | PD1; human IgG4 | Melanoma, non-small-cell lung cancer | 2014 |
Pembrolizumab | Keytruda | PD1; humanized IgG4 | Melanoma | 2014 |
Siltuximab | Sylvant | IL-6; chimeric IgG1 | Castleman's disease | 2014 |
Trastuzumab | Herceptin | HER2; humanized IgG1 | Breast cancer | 1998 |
Rituximab | MabThera, Rituxan | CD20; chimeric IgG1 | Non-Hodgkin lymphoma | 1997 |
Autoimmune/immunology | ||||
Vedolizumab | Entyvio | α4β7 integrin; humanized IgG1 | Ulcerative colitis, Crohn's disease | 2014 |
Ustekinumab | Stelara | IL-12/23; human IgG1 | Psoriasis | 2009 |
Certolizumab pegol | Cimzia | TNF-α; humanized Fab, pegylated | Crohn's disease | 2008 |
Adalimumab | Humira, Amjevita | TNF-α; human IgG1 | Rheumatoid arthritis | 2002 |
Infliximab | Remicade, Inflectra | TNF-α; chimeric IgG1 | Inflammatory bowel disease, rheumatoid arthritis | 1998 |
Rare diseases/neurology | ||||
Eculizumab | Soliris | C5; humanized IgG2/4 | Paroxysmal nocturnal hemoglobinuria, atypical hemolytic-uremic syndrome | 2007 |
Natalizumab | Tysabri | α4 integrin; humanized IgG4 | Multiple sclerosis | 2004 |
This list is not meant to be exhaustive. Currently, there are over 60 FDA-approved MAbs. A complete and frequently updated list of approved MAbs can be found online at www.antibodysociety.org.