Table 1.1.
Antibodies approved by the US FDA for clinical use. In addition to all approved monoclonal antibodies for prevention and treatment (indicated in bold) as of March 2008 the list (not exhaustive) also includes several polyclonal antibody preparations and a monoclonal antibody for imaging. Note that the same antibody can be approved for different indications at different times. The antibodies are arranged alphabetically according to their brand names
| Product | Company | Application | FDA Approval Date |
|---|---|---|---|
| Avastin™ (bevacizumab) | Genentech | First-line treatment, in combination with 5-fluorouracil, of metastatic colorectal cancer; second-line treatment of metastatic colorectal cancer with 5-fluorouracil-based chemotherapy; use in combination with carboplatin and paclitaxel chemotherapy for first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small-cell lung cancer |
Feb. 2004 Jun. 2006 Oct. 2006 |
| BEXXAR ® (Tositumomab and tositumomab I-131) | Corixa Corp. and GlaxoSmithKline | CD20-positive, follicular NHL refractory to rituximab; CD20-positive relapsed or refractory, low-grade, follicular or transformed NHL |
Jun. 2003 Jan. 2005 |
| Campath ®(alemtuzumab) | Millennium Pharmaceuticals, Inc. and Berlex Laboratories, Inc. | B-cell chronic lymphocytic leukemia in patients who have been treated with alkylating agents and who have failed fludarabine therapy | May 2001 |
| CEA-Scan® (acritumomab; technetium-99 labeled) | Immunomedics, Inc. | Imaging agent for metastatic colorectal cancer | Jun. 1996 |
| CroFab™ (crotalidae polyvalent immune Fab, ovine) | Protherics, plc, and Savage Laboratories (unit of Altana, Inc.) | Rattlesnake antivenom | Oct. 2000 |
| CytoGam® (CMV immune globulin IV) | MedImmune, Inc. | Prevention of cytomegalovirus (CMV) disease associated with kidney, lung, liver, pancreas, and heart transplants; Prevention of CMV in transplant patients |
Apr. 1990 Dec. 1998 |
| DigiFab™ (digoxin immune fab [ovine]) | Protherics, plc | Digoxin toxicity | Sep. 2001 |
| Erbitux™ (cetuximab) | ImClone Systems Inc. and Bristol-Myers Squibb | Patients with metastatic colorectal cancer who are refractory to or intolerant of irinotecan; use with radiation therapy for treating advanced squamous cell carcinoma of the head and neck, and as a single agent in advanced disease not responsive to platinum-based treatment |
Feb. 2004 Mar. 2006 |
| GAMMAGARD® (Immune Globulin Intravenous (Human) Solution) | Baxter HealthCare Corp. | Treatment of primary immunodeficiency disorders associated with defects in humoral immunity | Apr. 2005 |
| Herceptin ® (trastuzumab) | Genentech, Inc. | Treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein | Sep. 1998 |
| HUMIRA™(adalimumab) | Cambridge Antibody Technologies and Abbott Laboratories | Patients with moderately to severely active rheumatoid arthritis who have had insufficient response to one or more traditional disease-modifying antirheumatic drugs; expanded indication to include improvement in physical function for adult patients with moderately-to-severely active RA; reducing signs and symptoms of active arthritis in patients with psoriatic arthritis; reducing signs and symptoms of active ankylosing spondylitis |
Dec. 2002 Jul. 2004 Oct. 2005 Jul. 2006 |
| LUCENTIS™ (ranibizumab injection) | Genentech | Wet age-related macular degeneration | Jun. 2006 |
| Mylotarg™(gemtuzumab ozogamicin) | UCB and Wyeth | Human antibody linked to calicheamicin (chemotherapeutic) for treatment of CD33-positive acute myeloid leukemia in patients 60 and older in first relapse who are not considered candidates for cytotoxic chemotherapy | May 2000 |
| Orthoclone OKT3 ®(muromomab-CD3) | Ortho Biotech, Inc. (subsidiary of Johnson & Johnson) | Reversal of acute kidney transplant rejection | Jun. 1986 |
| RAPTIVA™ (efalizumab) | Xoma, Ltd. and Genentech | Chronic moderate-to-severe psoriasis | Oct. 2003 |
| REMICADE ®(infliximab) | Centocor, Inc. (subsidiary of Johnson & Johnson) | Short-term management of moderately-to-severely-active Crohn’s disease including those patients with fistulae; treatment of patients with rheumatoid arthritis who have had inadequate response to methotrexate alone; improving physical function in patients with moderately-to-severely-active rheumatoid arthritis who have had an inadequate response to methotrexate; reducing signs and symptoms, and inducing and maintaining clinical remission in patients with moderately-to-severely-active Crohn’s disease who have had an inadequate response to conventional therapy; reduction of draining enterocutaneous and rectovaginal fistulas and for maintaining fistula closure in patients with fistulizing Crohn’s disease; FDA-approved expanded label for Remicade in combination with methotrexate as first-line regimen in patients with moderate-to-severe rheumatoid arthritis; ankylosing spondylitis; reducing the signs and symptoms of psoriatic arthritis; expanded label to treat ulcerative colitis; Pediatric Crohn’s disease; inhibiting progression of structural damage and improving physical function in patients with psoriatic arthritis; chronic severe plaque psoriasis in adults |
Aug. 1998 Nov. 1999 Feb. 2002 Jun. 2002 Apr. 2003 Sep. 2004 Dec. 2004 May 2005 Sep. 2005 May 2006 Aug. 2006 Sep. 2006 |
| ReoPro™ (abciximab) | Centocor, Inc. (subsidiary of Johnson & Johnson) and Eli Lilly and Company | Reduction of acute blood clot-related complications for high-risk angioplasty patients; reduction of acute blood clot complications for all patients undergoing any coronary intervention; treatment of unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours |
Dec. 1994 Dec. 1997 |
| RespiGam® (immune globulin enriched in antibodies against syncytial virus [RSV]) | MedImmune, Inc. | Prevention of RSV in infants under 2 with bronchopulmonary dysplasia or history of prematurity | Jan. 1996 |
| Rituxan™ (rituximab) | Biogen Idec and Genentech, Inc. | Treatment of relapsed or refractory low-grade or follicular, CD20-positive B-cell NHL; use with methrotrexate to reduce signs and symptoms of moderately-to-severely-active rheumatoid arthritis who have inadequately responded to tumor necrosis factor (TNF) antagonist therapies; first-line treatment of diffuse large B-cell, CD20+, NHL in combination with anthracycline-based chemotherapy regimens; low-grade CD20+, B-cell NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP (cyclophosphamide, vincristine, and prednisolone) therapy; First-line treatment of previously untreated patients with follicular CD20+, B-cell NHL in combination with CVP |
Nov. 1997 Feb. 2006 Feb. 2006 Sep. 2006 Sep. 2006 |
| Simulect ® (basiliximab) | Novartis Pharmaceutical Corp. | Prevention of acute rejection episodes in kidney transplant recipients; prevention of rejection in combination with triple immunosuppressive therapy in renal transplant; use in pediatric renal transplant; and use of IV bolus injection |
May 1998 Mar. 2001 |
| Soliris ® (eculizumab) | Alexion Pharmaceuticals, Inc. | The first product for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare type of blood disorder that can lead to disability and premature death | Mar. 2007 |
| Synagis™ (palivizumab) | MedImmune, Inc. | Prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease | Jun. 1998 |
| TYSABRI ® (formerly ANTEGREN ®) (natalizumab) | Biogen Idec and Elan Corp. | Reduction of clinical relapse frequency in relapsing forms of multiple sclerosis; supplemental BLA approved, allowing market reintroduction (following withdrawal in 2005) as monotherapy for relapsing MS; treatment of moderate-to-severe Crohn’s disease in patients with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn's disease therapies |
Nov. 2004 Jun. 2006 Jan. 2008 |
| Vectibix™ (panitumumab) | Amgen | Metastatic colorectal cancer | Sep. 2006 |
| VIGIV, Vaccinia Immune Globulin Intravenous (intravenous immune globulin) | DynPort Vaccine | For the treatment and modifications of aberrant infections induced by vaccinia virus that include its accidential implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard; eczema vaccinatum; progressive vaccinia; severe generalized vaccinia, and vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions. | Feb. 2005 |
| WinRho SDF® (Rho[D] immune globulin) | Nabi Biopharmaceuticals | Prevention of Rh isoimmunization in pregnant women and the treatment of immune thrombocytopenic purpura | Mar. 1995 |
| Xolair ® (omalizumab) | Genentech, Tanox, Inc. and Novartis Pharmaceuticals | Moderate-to-severe persistent asthma in adults and adolescents | Jun. 2003 |
| Zenapax ®(daclizumab) | Hoffmann-La Roche, Inc., and Protein Design Labs | Humanized monoclonal antibody for prevention of kidney transplant rejection | Dec. 1997 |
| Zevalin ®(Ibritumomab tiuxetan) | IDEC Pharmaceuticals Corporation | Treatment for low-grade B-cell NHL; the first monoclonal antibody that is combined with a radioactive chemical (Y-90); must be used along with Rituxan for patients who have not responded to standard chemotherapy treatments or to the use of Rituxan alone. | Feb. 2002 |