Table 1.
FDA-approved therapeutic monoclonal antibodies
| Generic name (Trade) | Approval date | First approved indication |
| Abciximab (Reopro) | 12/22/1994 | Adjunct to percutaneous transluminal coronary angioplasty or atherectomy (PTCA) for the prevention of acute cardiac ischemic complications in patients at high risk for abrupt closure of the treated coronary vessel. |
| Adalimumab (Humira) | 12/31/2002 | Reducing signs and symptoms and inhibiting the progression of the structural damage in adult patients with moderately to severly active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDS). |
| Alemtuzumab (Campath-1H) | 05/07/2001 | Treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy. |
| Basiliximab (Simulect) | 05/12/1998 | Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids. |
| Bevacizumab (Avastin) | 02/26/2004 | First-line treatment of patients with metastatic carcinoma of the colon and rectum in combination with intravenous 5-fluorouracil-based chemotherapy. |
| Certolizumab pegol (Cimzia) | 04/22/2008 | Reducing the signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. |
| Cetuximab (Erbitux) | 02/12/2004 | In combination with irinotecan, treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy; administered as a single agent, treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy. |
| Daclizumab (Zenapax) | 12/10/1997 | Prophylaxis of acute organ rejection in patients receiving renal transplants, to be used as a part of an immunosuppressive regimen that includes cyclosporine and corticosteroids. |
| Eculizumab (Soliris) | 03/16/2007 | Treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis. |
| Efalizumab (Raptiva) | 10/27/2003 | Treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. |
| Gemtuzumab ozogamicin (Mylotarg) | 05/17/2000 | Treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy. |
| Ibritumomab tuixetan (Zevalin) | 02/19/2002 | Ibritumomab Tiuxetan, as part of a specific therapeutic regimen, is indicated for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan) refractory follicular non-Hodgkin's lymphoma. The therapeutic regimen includes Rituximab, Indium-111 Ibritumomab Tiuxetan and Yttrium-90 Ibritumomab Tiuxetan. |
| Infliximab (Remicade) | 08/24/1998 | Treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms, in patients who have an inadequate response to conventional therapies; and treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s). |
| Muromonab-CD3 (Orthoclone-Okt) | 06/19/1986 | Reversal of acute kidney transplant rejection. |
| Natalizumab (Tysabri) | 11/23/2004 | Treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. |
| Omalizumab (Xolair) | 06/20/2003 | Omalizumab is indicated for adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. |
| Palivizumab (Synagis) | 06/19/1998 | Prophylaxis of serious lower respiratory tract disease, caused by respiratory syncytial virus, in pediatric patients at high risk of RSV disease. |
| Panitumumab (Vectibix) | 09/27/2006 | Treatment of EGFR-expressing metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens. |
| Ranibizumab (Lucentis) | 06/30/2006 | Treatment of patients with neovascular (wet) age-related macular degeneration. |
| Rituximab (Rituxan) | 11/26/1997 | Treatment of patients with relapsed or refractory low-grade or follicular, B-cell non-Hodgkin's lymphoma. |
| Tositumomab-I131 (Bexxar) | 06/27/2003 | Tositumomab and Iodine I 131 Tositumomab, administered as a therapeutic regimen, are indicated for the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy. |
| Trastuzumab (Herceptin) | 09/25/1998 | Treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease. Trastizumab in combination with paclitaxel is indicated for treatment of patients with metastatic breast cancer whose tumors overexpress HER2 protein and who have not received chemotherapy for their metastatic disease. |
Source: FDA, www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed: May 25, 2008.