Monoclonal Antibody Therapy - FDA Approved Therapeutic Antibodies

FDA Approved Therapeutic Antibodies

For a more comprehensive list, see List of monoclonal antibodies.

The first FDA-approved therapeutic monoclonal antibody was a murine IgG2a CD3 specific transplant rejection drug, OKT3 (also called muromonab), in 1986. This drug found use in solid organ transplant recipients who became steroid resistant. Hundreds of therapies are undergoing clinical trials. Most are concerned with immunological and oncological targets.

Example FDA approved therapeutic monoclonal antibodies

Antibody	Brand name	Company	Approval date	Type	Target	Indication (Targeted disease)
Abciximab	ReoPro	Eli Lilly	1994	chimeric	inhibition of glycoprotein IIb/IIIa	Cardiovascular disease
Adalimumab	Humira	Abbot	2002	human	inhibition of TNF-α signaling	Several auto-immune disorders
Alemtuzumab	Campath	Genzyme	2001	humanized	CD52	Chronic lymphocytic leukemia
Basiliximab	Simulect	Novartis	1998	chimeric	IL-2Rα receptor (CD25)	Transplant rejection
Belimumab	Benlysta	GlaxoSmithKline	2011	human	inihibition of B- cell activating factor	Systemic lupus erythematosus
Bevacizumab	Avastin	Genentech/Roche	2004	humanized	Vascular endothelial growth factor (VEGF)	Colorectal cancer, Age related macular degeneration (off-label)
Brentuximab vedotin	Adcetris		2011	Chimeric	CD30	Anaplastic large cell lymphoma (ALCL) and Hodgkin lymphoma
Canakinumab	Ilaris	Novartis	2009	Human	IL-1β	Cryopyrin-associated periodic syndrome (CAPS)
Cetuximab	Erbitux	Bristol-Myers Squibb/Eli Lilly/Merck KGaA	2004	chimeric	epidermal growth factor receptor	Colorectal cancer, Head and neck cancer
Certolizumab pegol	Cimzia	UCB (company)	2008	humanized	inhibition of TNF-α signaling	Crohn's disease
Daclizumab	Zenapax	Genentech/Roche	1997	humanized	IL-2Rα receptor (CD25)	Transplant rejection
Denosumab	Prolia, Xgeva	Amgen	2010	Human	RANK Ligand inhibitor	Postmenopausal osteoporosis, Solid tumor`s bony metasteses
Eculizumab	Soliris	Alexion Pharmaceuticals	2007	humanized	Complement system protein C5	Paroxysmal nocturnal hemoglobinuria
Efalizumab	Raptiva	Genentech/Merck Serono	2002	humanized	CD11a	Psoriasis
Gemtuzumab	Mylotarg	Wyeth	2000	humanized	CD33	Acute myelogenous leukemia (with calicheamicin)
Golimumab	Simponi	Johnson & Johnson/Merck & Co, Inc.	2009	Human	TNF-alpha inihibitor	Rheumatoid arthritis, Psoriatic arthritis, and Ankylosing spondylitis
Ibritumomab tiuxetan	Zevalin	Spectrum Pharmaceuticals, Inc.	2002	murine	CD20	Non-Hodgkin lymphoma (with yttrium-90 or indium-111)
Infliximab	Remicade	Janssen Biotech, Inc./Merck & Co	1998	chimeric	inhibition of TNF-α signaling	Several autoimmune disorders
Ipilimumab ( MDX-101 )	Yervoy		2011	Human	blocks CTLA-4	Melanoma
Muromonab-CD3	Orthoclone OKT3	Janssen-Cilag	1986	murine	T cell CD3 Receptor	Transplant rejection
Natalizumab	Tysabri	Biogen Idec/Élan	2006	humanized	alpha-4 (α4) integrin,	Multiple sclerosis and Crohn's disease
Ofatumumab	Arzerra		2009	Human	CD20	Chronic lymphocytic leukemia
Omalizumab	Xolair	Genentech/Novartis	2004	humanized	immunoglobulin E (IgE)	mainly allergy-related asthma
Palivizumab	Synagis	MedImmune	1998	humanized	an epitope of the RSV F protein	Respiratory Syncytial Virus
Panitumumab	Vectibix	Amgen	2006	human	epidermal growth factor receptor	Colorectal cancer
Ranibizumab	Lucentis	Genentech/Novartis	2006	humanized	Vascular endothelial growth factor A (VEGF-A)	Macular degeneration
Rituximab	Rituxan, Mabthera	Biogen Idec/Genentech	1997	chimeric	CD20	Non-Hodgkin lymphoma
Tocilizumab ( or Atlizumab )	Actemra and RoActemra		2010	Humanised	Anti- IL-6R	Rheumatoid arthritis
Tositumomab	Bexxar	GlaxoSmithKline	2003	murine	CD20	Non-Hodgkin lymphoma
Trastuzumab	Herceptin	Genentech	1998	humanized	ErbB2	Breast cancer

Recently, the bispecific antibodies, a novel class of therapeutic antibodies, have yielded promising results in clinical trials. In April 2009, the bispecific antibody catumaxomab was approved in the European Union.