Table 2.
Monoclonal antibodies approved by the EMA and FDA for cancer treatment and diagnosis −2017 Update.
| Trade name | Active principle name | Company | Target | Type | Year of EU EMA approval | Year of FDA approval | Therapeutic indication(s) |
|---|---|---|---|---|---|---|---|
| Bavencio® | Avelumab | Merck Sharp & Dohme Limited | PD-L1 | Human IgG1/κ | Not approved* | 2017 | Metastatic Merkel cell carcinoma |
| Imfinzi® | Durvalumab | Astrazeneca UK | PD-L1 | Human IgG1/κ | Not approved* | 2017 | Metastatic urothelial carcinoma |
| Lartruvo | Olaratumab | Eli Lilly | PDGFR-α | Human IgG1 | 2016 | 2016 | Sarcoma |
| Darzalex® | Daratumumab | Janssen-Cilag | CD38 | Human IgG1/κ | 2016 | 2015 | Multiple myeloma |
| Empliciti | Elotuzumab | Bristol-Myers Squibb | SLAMF7 | Human IgG1 | 2016 | 2015 | Multiple myeloma |
| Portrazza | Necitumumab | Eli Lilly | EGFR | Human IgG1 | 2016 | 2015 | Carcinoma, non-small-cell lung |
| Tecentriq® | Atezolizumab | Genentech (Roche) | PD-L1 | Human IgG1 | Not approved* | 2016 | Metastatic non-small cell lung cancer |
| Opdivo | Nivolumab | Bristol-Myers Squibb Pharma | PD-1 | Human IgG4 | 2015 | 2015 | Carcinoma; non-small-cell lung carcinoma; renal cell Hodgkin disease melanoma |
| Unituxin | Dinutuximab | United Therapeutics Europe | GD2 | Human IgG1/κ | 2015 (1) | 2015 | Neuroblastoma |
| Blincyto® | Bevacizumab | Amgen Europe | CD19 | BiTEs | 2015 | 2014 | Precursor cell lymphoblastic leukemia-lymphoma |
| Keytruda® | Pembrolizumab | Merck Sharp & Dohme Limited | PD-1 | Human IgG4 | 2015 | 2014 | Melanoma |
| Cyramza | Ramucirumab | Eli Lilly | VEGF | Human IgG1 | 2014 | 2014 | Stomach neoplasms |
| Perjeta® | Pertuzumab | Roche | HER2 | Humanized IgG1 | 2013 | 2012 | Breast cancer |
| Gazyvaro® | Obinutuzumab | Roche | CD20 | Humanized IgG1 | Not approved* | 2013 | CLL |
| Vervoy® | Ipilimumab | BMS | CTLA-4 | Human IgG1 | 2011 | 2011 | Melanoma |
| Xgeva® | Denosumab | Amgen | RANKL | Human IgG2 | 2011 | 2011 | Prevention of SREs in patients with bone metastases from solid tumors |
| Arzerra® | Ofatumumab | Genmab and GSK | CD20 | Human IgG1 | 2010 | 2009 | Chronic lymphocytic leukemia |
| Removab® | Catumaxomab | Fresenius | EpCAM and CD3 | Trifunctional MAb IgG2a/IgG2b | 2009 | Not approved* | Malignant ascites in patients with EpCAM-positive carcinomas |
| Vectibix® | Panitumumab | Amgen | EGFR | Human IgG2 | 2007 | 2006 | Metastatic colorectal carcinoma |
| Proxinium® | Catumaxomab | Viventia (Eleven Biotherapeutics) | EpCAM | Humanized MAb | 2005 | 2005 | Head and neck cancer |
| Avastin® | Bevacizumab | Genentech (Roche) | VEGF | Humanized IgG1 | 2005 | 2004 | Metastatic colorectal cancer; non-small cell lung cancer; metastatic breast cancer; glioblastoma multiforme; metastatic renal cell carcinoma |
| Erbitux® | Cetuximab | ImClone (Eli Lilly), Merck Serono and BMS | EGFR | Chimeric IgG1 | 2004 | 2004 | Head and neck cancer; colorectal cancer |
| Campath® | Alemtuzumab | Millennium Pharmaceuticals and Genzyme | CD52 | Humanized IgG1 | 2001 | 2001 | B-cell chronic lymphocytic leukemia |
| Herceptin® | Trastuzumab | Genentech (Roche) | HER-2 | Humanized IgG1 | 2000 | 1998 | Breast cancer; metastatic gastric or gastroesophageal junction adenocarcinoma |
| Rituxan® MabThera® | Rituximab | Biogen Idec, Genentech (Roche) | CD20 | Chimeric IgG1 | 1998 | 1997 | Non-Hodgkin's lymphoma; chronic lymphocytic leukemia; rheumatoid arthritis |
| CONJUGATED MONOCLONAL ANTIBODIES FOR CANCER TREATMENT | |||||||
| Zevalin® | Ibritumomab tiuxetan | Biogen Idec | CD20 | Murine IgG1 | 2004 | 2002 | Non-Hodgkin's lymphoma |
| Bexxar® | Tositumomab and iodine 131 tositumomab | Corixa and GSK | CD20 | Murine IgG2a | Not approved* | 2003 | Non-Hodgkin's lymphoma |
| Mylotarg® | Gemtuzumab ozogamicin | Wyeth | CD33 | Humanized IgG4/toxin conjugate | Not approved* | 2000 (2) | Acute myeloid leukemia (AML) |
| Kadcyla® | Trastuzumab emtansine | Roche | HER2 | Humanized IgG1 as ADC | 2013 | 2013 | Breast cancer |
| Adcetris® | Brentuximab | Seattle Genetics | CD30 + MMAE | Chimeric IgG1 as ADC (antibody drug conjugate) | 2012 | 2011 | Hodgkin lymphoma (HL), systemic anaplastic large cell lymphoma (ALCL) |
| DIAGNOSTIC MONOCLONAL ANTIBODIES FOR CANCER | |||||||
| Humaspect® | Votumumab | Organon Teknica | Cytokeratin tumor-associated antigen | Human Mab + 99mTc | 1998 (3) | Not approved* | Detection of carcinoma of the colon or rectum |
| LeukoScan® | Sulesomab | Immunomedics | NCA90 | Murine Fab fragment | 1997 | Not approved* | Diagnostic imaging for osteomyelitis |
| CEA-scan® | Arcitumomab | Immunomedics | Human CEA | Murine Fab fragment | 1996 (4) | 1996 | Detection of colorectal cancer |
| ProstaScint® | Capromab | Cytogen | Tumor surface antigen PSMA | Murine MAb | Not approved* | 1996 | Detection of prostate adenocarcinoma |
| Verluma® | Nofetumomab | Boehringer Ingelheim, NeoRx | Carcinoma-associated antigen | Murine Fab fragment | Not approved* | 1996 | Diagnostic imaging of small-cell lung cancer |
| OncoScint® | Satumomab | Cytogen | TAG-72 | Murine MAb | Not approved* | 1992 | Detection of colorectal and ovarian cancers |
*
Not yet approved by EMA or FDA; (1). Withdrawn from use in the European Union; (2). Withdrawn from the market in US in 2010; (3). Withdrawn from the market in EU in 2003; (4). Withdrawn from the market in EU in 2005.