Table 1.
Key Fc-fusion proteins and monoclonal antibodies (mAbs) in the clinic
| Trade name (generic name) | Description | Indication of first FDA approval | Stage | Company |
|---|---|---|---|---|
| Fc-fusion | ||||
| Nulojix (belatacept) | CTLA-4 fused to the Fc of human IgG1 | Organ rejection | FDA Approved (2011) | Bristol-Meyers Squibb |
| Eylea (aflibercept) | VEGFR1/VEGFR2 fused to the Fc of human IgG1 | Age related macular degeneration | FDA Approved (2011) | Regeneron Pharmaceuticals |
| Arcalyst (rilonacept) | IL-1R fused to the Fc of human IgG1 | Cryopyrin-associated periodic syndromes | FDA Approved (2008) | Regeneron Pharmaceuticals |
| NPlate (romiplostim) | Thrombopoietin-binding peptide fused to the Fc of human IgG1 | Thrombocytopenia in chronic immune thrombocytopenic purpura patients | FDA Approved (2008) | Amgen/Pfizer |
| Orencia (abatacept) | Mutated CTLA-4 fused to the Fc of human IgG1 | Rheumatoid arthritis | FDA Approved (2005) | Bristol-Meyers Squib |
| Amevive (alefacept) | LFA-3 fused to the Fc of human IgG1 | Psoriasis and transplant rejection | FDA Approved (2003) | Astellas Pharma |
| Enbrel (etanercept) | TNFR fused to the Fc of human IgG1 | Rheumatoid arthritis | FDA Approved (1998) | Amgen/Pfizer |
| mAbs | ||||
| Rituxan/MabThera (rituximab) | Chimeric mouse/human IgG1 targeting CD20 | B cell lymphomas | FDA Approved (2006) | Biogen Idec/Genentech Hoffman-La Roche (Europe) |
| Herceptin (trastuzumab) | Chimeric mouse/human IgG1 targeting HER2 | Breast cancer and gastroesophageal junction adenocarcinoma | FDA Approved (2006) | Genentech |
| Campath/Lemtrada (alemtuzumab) | Humanized IgG1 targeting CD52 on B and T lymphocytes | B cell chronic lymphocytic leukemia. In phase IIIa trials for multiple sclerosis | FDA Approved (2007) | Genzyme |
| Prolia/Xgeva (denosumab) | Fully human IgG2 targeting RANKL | Osteoporosis | FDA Approved (2010) | Amgen |
| Tysabri (natalizumab) | Humanized IgG4 tageting alpha-4 integrin | Multiple sclerosis and Crohn's disease | FDA Approved (2004) | Biogen Idec and Élan |
| Vectibix (panitumumab) | Fully human IgG2 targeting EGFR, ErbB-1 and HER1 | Metastatic colorectal cancer (in patients with non-mutated KRAS | FDA Approved (2006) | Amgen |
| Soliris (eculizumab) | Humanized IgG2/4κ targeting complement protein C5 | Paroxysmal nocturnal haemoglobinuria to reduce haemolysis | FDA Approved (2007) | Alexion Pharmaceuticals |
| Erbitux (cetuximab) | Chimeric mouse human IgG1 targeting EGFR, ErbB-1 and HER1 | Metastatic colorectal cancer (in patients with non-mutated KRAS | FDA Approved (2006) | Bristol-Myers Squibb and Eli Lilly |
| Avastin (bevacizumab) | Humanized IgG1 targeting VEGF | Metastatic colorectal cancer and HER2-negative metastatic breast cancer | FDA Approved (2008) Withdrawn (2011) | Genentech/Roche |
| Remicade (infliximab) | Chimeric mouse human IgG1 targeting TNF-α | Psoriasis, Crohn's disease, ankylosing spondylitis, rheumatoid arthritis | FDA Approved (1998) | Janssen Biotech/Schering-Plough |