Table I.
Therapeutic monoclonal antibodies in oncology.
| Name (trade name) | Species/Format (isotype) | Approval date* | Target | Indication° |
|---|---|---|---|---|
| Edrecolomab (Panorex) | Mouse (IgG2a, κ) | 1995¥ (Ger.)°° | EpCAM | CRC** |
| Rituximab (Mabthera)+ | Chimeric (IgG1, κ) | 1997 | CD20 | NHL** |
| Trastuzumab (Herceptin) | Humanized (IgG1, κ) | 1998 | HER2/neu | Breast Cancer |
| Gemtuzumab (Mylotarg) | Humanized (IgG4, κ)# | 2000¥ | CD33 | AML** |
| Alemtuzumab (MabCampath) | Humanized (IgG1, κ) | 2001 | CD52 | CLL** |
| Ibritumomab tiuxetan (Zevalin) | Mouse (IgG1, κ) (conjugated to Ind111/Y99) | 2002 | CD20 | NHL** |
| Tositumomab-I131 (Bexxar) | Mouse (IgG2a, κ) (conjugated to I131) | 2003 | CD20 | NHL** |
| I131-Vivatuxin/I131-chTNT | Chimeric IgG | 2003 (PRC)°° | NT Ag*** | Lung Cancer |
| Cetuximab (Erbitux) | Chimeric (IgG1, κ) | 2004 | EGF-R | Head & Neck Cancer |
| Bevacizumab (Avastin) | Humanized (IgG1, κ) | 2004 | VEGF-A | CRC** |
| Metuximab (I131-Licartin) | Chimeric (Fab’)2 | 2005 (PRC) | CD147 | HCC** |
| Nimotuzumab (TheraCIM) (BIOMab EGFR) (CIMAHer) | Humanized (IgG1, κ) | 2005++ (Singapore) (India) (Cuba) | EGF-R | Head & Neck Cancer Nasopharyngeal cancer, Glioma |
| Panitimumab (Vectibix) | Human (IgG2, κ) | 2006 | EGF-R | CRC |
| Catumaxomab (Removab) | Mouse IgG2a/rat IgG2b°°° | 2009 | EpCAM/CD3 | Malignant Ascites |
| Ofatumumab (Arzerra) | Human (IgG1, κ) | 2009 | CD20 | CLL |
| Denosumab (Prolia) | Human (IgG2, κ) | 2010 | RANK-L | Bone Metastases |
| Ipilimumab (Yervoy) | Human (IgG1, κ) | 2011 | CTLA-4 | Melanoma |
| Brentuximab vedotin (Adcentris) | Chimeric (IgG1, κ)## | 2011 | CD30 | Hodgkin Lymphoma, ALCL** |
| Pertuzumab (Perjeta) | Humaniszed (IgG1, κ) | 2012 | HER2/neu | Breast Cancer |
First year registration (EMA, FDA or SFDA). EMA: European Medicines Agency (ex-EMEA) (EU); FDA: Food and Drug Administration (USA); SFDA: State Food and Drug Administration (RPC).
Only the first indication is indicated (except denosumab whose first indication was post-menopausal osteoporosis).
ALCL: anaplastic large-cell lymphoma; CRC: colorectal cancer; HCC: hepatocellular carcinoma; AML: acute myeloid leukemia; CLL: chronic lymphocytic leukemia; NHL: non-Hodgkin lymphoma.
Discontinued (edrecolomab: withdrawn from market after two phase III trials showing no patient benefit; gemtuzumab withdrawn from market in 2010 due to unfavourable risk/benefit ratio).
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