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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).

+

Rituxan™ in the USA.

**

ALCL: anaplastic large-cell lymphoma; CRC: colorectal cancer; HCC: hepatocellular carcinoma; AML: acute myeloid leukemia; CLL: chronic lymphocytic leukemia; NHL: non-Hodgkin lymphoma.

#

Immunoconjugated to ozogamycin.

¥

Discontinued (edrecolomab: withdrawn from market after two phase III trials showing no patient benefit; gemtuzumab withdrawn from market in 2010 due to unfavourable risk/benefit ratio).

°°

Ger.: Federal Republic of Germany; PRC: People’s Republic of China.

***

NT Ag: necrotic tumor antigen (TNT: tumor necrotic therapy).

++

Orphan drug status granted by FDA and EMA for glioma treatment and by EMA for pancreatic cancer treatment.

°°°

Quadroma: bispecific antibody obtained by fusion of two hybridomas.

##

Immunoconjugated to monomethyl auristatin E (MMAE).

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