. 2009 Jan-Feb;1(1):56–66. doi: 10.4161/mabs.1.1.7246

Table 2.

FDA-approved supplemental indications for monoclonal antibodies

Generic name (Trade)	Supplemental indications (approval date)
Abciximab (Repro)	• Percutaneous coronary intervention including unstable angina; adjunct (11/5/1997)^a
Adalimumab (Humira)	• Ankylosing spondylitis (07/31/2006)^a
	• Psoriatic arthritis
	- improving physical function; inhibiting structural damage (11/09/2006)^a
	- treatment (10/03/2005)^b
	• Crohn's disease (02/27/2007)^a
	• Plaque psoriasis (01/18/2008)^a
	• Rheumatoid Arthritis
	- improving physical function (07/30/2004)^b
	- treatment of recent diagnosis and not yet on methotrexate (10/3/2005)^b
	• Juvenile idiopathic arthritis (02/21/2008)^b
Alemtuzumab (Campath-1H)	• Leukemia; monotherapy (09/19/2007)^b
Basiliximab (Simulect)	• Kidney transplant rejection
	- pediatric use (03/23/2001)^a
	- IV bolus use (03/23/2001)^a
	- Combination therapy (03/23/2001)^a
Bevacizumab (Avastin)	• Lung cancer; first-line combination therapy (10/11/2006)^a
	• Breast cancer; combination therapy in patients not yet receiving chemo therapy (02/22/2008)^a
	• Colorectal cancer; second-line adjunct treatment (06/20/2006)^b
Cetuximab (Erbitux)	• Head and neck cancer
	- combination therapy (03/01/2006)^a
	- monotherapy (03/01/2006)^a
	• Colorectal cancer; monotherapy (10/02/2007)^b
Daclizumab (Zenapax)	• Kidney transplant rejection; pediatric use (07/29/2002)^a
Ibritumomab tuixetan (Zevalin)	• Non-Hodgkin's lymphoma; removed transformed B-cell non-Hodgkin's lymphoma as an indication (03/25/2008)^a
Infliximab (Remicade)	• Rheumatoid Arthritis
	- reducing signs and symptoms (11/10/1999)^a
	- inhibiting structural damage (12/29/2000)^b
	- improve physical function (02/27/2005)^b
	- treatment in early stages not yet treated with methotrexate (09/29/2004)^b
	• Psoriatic arthritis
	- treatment (05/13/2005)^b
	- improve physical function (08/11/2006)^b
	• Active arthritis; inhibit structural damage (08/11/2006)^b
	• Crohn's disease
	- pediatric use (05/19/2006)^a
	- reducing signs and symptoms; inducing and maintaining remission (06/28/2002)^b
	- reducing number of draining fistulas and maintaining fistula closure fistulizing Crohn's disease (04/01/2003)^b
	• Ankylosing Spondylitis (12/17/2004)^a
	• Ulcerative colitis
	- treatment (09/15/2005)^a
	- maintenance of clinical remission and mucosal healing (10/13/2006)^b
	• Plaque psoriasis (09/26/2006)^a
Muromonab-CD3 (Orthoclone-Okt)	• Allograft rejection in kidney transplants (09/14/1992)^a
	• Allograft rejection in heart and liver transplants (06/08/1993)^a
Natalizumab (Tysabri)	• Crohn's disease; inducing and maintaining clinical response and remission (02/14/2008)^a
Rituximab (Rituxan)	• Rheumatoid arthritis
	- combination therapy (02/28/2006)^a
	- slow progression of structural damage (01/25/2008)^b
	• Non-Hodgkin's lymphoma; first-line combination therapy (09/29/2006)^b
Tositumomab-I131 (Bexxar)	• Non-Hodgkin's lymphoma (12/22/2004)^b
Trastuzumab (Herceptin)	• Breast cancer
	- adjuvant combination therapy (11/16/2006)^b
	- adjuvant monotherapy (01/18/2008)^b

New Indication: New indication as noted in the FDA supplemental approval letter.

Expanded Indication: Expanded indication as noted in the FDA supplemental approval letter. Source: FDA, www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed: May 26, 2008.