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Antibody Society ::Approved Mabs
 


Therapeutic monoclonal antibodies approved or in review in the European Union or United States

Note: Information current as of 28 July, 2014

International non-proprietary 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 1986* (1986#)
Abciximab Reopro Anti-GPIIb/IIIa; Chimeric IgG1 Fab Prevention of blood clots in angioplasty 1995* (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); #
Palivizumab Synagis Anti-RSV; Humanized IgG1 Prevention of respiratory syncytial virus infection 1999 (1998)
Infliximab Remicade Anti-TNF; Chimeric IgG1 Crohn 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#)
Alemtuzumab MabCampath, Campath-1H Anti-CD52; Humanized IgG1 Chronic myeloid leukemia 2001 (2001)
Adalimumab Humira Anti-TNF; Human IgG1 Rheumatoid arthritis 2003 (2002)
Tositumomab-I131 Bexxar Anti-CD20; Murine IgG2a Non-Hodgkin lymphoma NA (2003)
Efalizumab Raptiva Anti-CD11a; Humanized IgG1 Psoriasis 2004 (2003); #
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 (2011)
Ipilimumab Yervoy Anti-CTLA-4; Human IgG1 Metastatic melanoma 2011 (2011)
Brentuximab vedotin Adcetris Anti-CD30; Chimeric IgG1; immunoconjugate Hodgkin lymphoma 2012 (2011)
Pertuzumab Perjeta Anti-HER2; humanized IgG1 Breast Cancer 2013 (2012)
Raxibacumab (Pending) Anti-B. anthrasis PA; Human IgG1 Anthrax infection NA (2012)
Trastuzumab emtansine Kadcyla Anti-HER2; humanized IgG1; immunoconjugate Breast cancer 2013 (2013)
Vedolizumab Entyvio Anti-alpha4beta7 integrin; humanized IgG1 Ulcerative colitis, Crohn disease 2014 (2014)
Ramucirumab Cyramza Anti-VEGFR2; Human IgG1 Gastric cancer In review (2014)
Obinutuzumab Gazyva Anti-CD20; Humanized IgG1; Glycoengineered Chronic lymphocytic leukemia In review (2013)
Siltuximab Sylvant Anti-IL-6; Chimeric IgG1 Castleman disease In review (2014)
Secukinumab (Pending) Anti-IL-17a; Human IgG1 Immunosuppression In review (In review)
Nivolumab (Pending) Anti-PD1; Human IgG4 Melanoma NA (NA) [Approved in Japan]
Pembrolizumab
(previously named Lambrolizumab)
(Pending) Anti-PD1; Humanized IgG4 Melenoma In review (In review)
Dinutuximab (Pending) Anti-GD2; Chimeric IgG1 Neuroblastoma In review (NA)

*Country-specific approval; approved under concertation procedure;
#Voluntarily withdrawn from market.

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.

Source: Janice M. Reichert, Editor-in-Chief, mAbs.
      

This page last modifie29 July, 2014-> by Berend Tolner

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