Monoclonal antibody therapy
Antibody Brand name Company Approval date Route Type Target Indication ( Targeted disease ) BLA STN Drug Label
abciximab ReoPro Centocor 12/22/1994 intravenous chimeric Fab GPIIb/IIIa Percutaneous coronary intervention 103575 Link
adalimumab Humira Abbvie 12/31/2002 subcutaneous fully human TNF Rheumatoid arthritis 125057 Link
adalimumab-atto Amjevita Amgen 9/23/2016 subcutaneous fully human , biosimilar TNF Rheumatoid arthritis Juvenile idiopathic arthritis Psoriatic arthritis Ankylosing spondylitis Crohn 's disease Ulcerative colitis Plaque psoriasis 761024 Link
ado-trastuzumab emtansine Kadcyla Genentech 2/22/2013 intravenous humanized , antibody-drug conjugate HER2 Metastatic breast cancer 125427 Link
alemtuzumab Campath , Lemtrada Genzyme 5/7/2001 intravenous humanized CD52 B-cell chronic lymphocytic leukemia 103948 Link
alirocumab Praluent Sanofi Aventis 7/24/2015 subcutaneous fully human PCSK9 Heterozygous familial hypercholesterolemia Refractory hypercholesterolemia 125559 Link
atezolizumab Tecentriq Genentech 5/18/2016 intravenous humanized PD-L1 Urothelial carcinoma 761034 Link
atezolizumab Tecentriq Genentech 10/18/2016 intravenous humanized PD-L1 Urothelial carcinoma Metastatic non-small cell lung cancer 761041 Link
avelumab Bavencio EMD Serono 3/23/2017 intravenous fully human PD-L1 Metastatic Merkel cell carcinoma 761049 Link
basiliximab Simulect Novartis 5/12/1998 intravenous chimeric IL2RA Prophylaxis of acute organ rejection in renal transplant 103764 Link
belimumab Benlysta Human Genome Sciences 3/9/2011 intravenous fully human BLyS Systemic lupus erythematosus 125370 Link
bevacizumab Avastin Genentech 2/26/2004 intravenous humanized VEGF Metastatic colorectal cancer 125085 Link
bezlotoxumab Zinplava Merck 10/21/2016 intravenous fully human Clostridium difficile toxin B Prevent recurrence of Clostridium difficile infection 761046 Link
blinatumomab Blincyto Amgen 12/3/2014 intravenous mouse , bispecific CD19 Precursor B-cell acute lymphoblastic leukemia 125557 Link
brentuximab vedotin Adcetris Seattle Genetics 9/19/2011 intravenous chimeric , antibody-drug conjugate CD30 Hodgkin lymphoma Anaplastic large-cell lymphoma 125388 Link
brodalumab Siliq Valeant 2/15/2017 subcutaneous chimeric IL17RA Plaque psoriasis 761032 Link
canakinumab Ilaris Novartis 6/17/2009 subcutaneous fully human IL1B Cryopyrin-associated periodic syndrome 125319 Link
capromab pendetide ProstaScint Cytogen 10/28/1996 intravenous murine , radiolabeled PSMA Diagnostic imaging agent in newly diagnosed prostate cancer or post- prostatectomy 103608 Link
certolizumab pegol Cimzia UCB ( company ) 4/22/2008 subcutaneous humanized TNF Crohn 's disease 125160 Link
cetuximab Erbitux ImClone Systems 2/12/2004 intravenous chimeric EGFR Metastatic colorectal carcinoma 125084 Link
FDA-approved therapeutic antibodies
For a more comprehensive list , see List of therapeutic 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 . [ 31 ] Hundreds of therapies are undergoing clinical trials . Most are concerned with immunological and oncological targets .
Monoclonal antibody therapy is a form of immunotherapy that uses monoclonal antibodies (mAb) to bind monospecifically to certain cells or proteins. The objective is that this treatment will stimulate the patient's immune system to attack those cells. Alternatively, in radioimmunotherapy a radioactive dose localizes a target cell line, delivering lethal chemical doses. More recently antibodies have been used to bind to molecules involved in T-cell regulation to remove inhibitory pathways that block T-cell responses. This is known as immune checkpoint therapy. It is possible to create a mAb that is specific to almost any extracellular/cell surface target. Research and development is underway to create antibodies for diseases (such as rheumatoid arthritis, multiple sclerosis, Alzheimer's disease, Ebola and different types of cancers).