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. 2021 Dec 24;14(1):87. doi: 10.3390/cancers14010087

Table 11.

Features of the monoclonal antibody drugs approved by the Food and Drug Administration (FDA) from 2011 to 2021. The order of drugs is tabulated in order of most recent to oldest registration date.

No. Generic Name of Drug Brand Name
and Company		 First FDA/EMA Approved Date Class Molecular Target Route of Administration Indication Adverse Effects Reference
1 Rituximab-arrx RIABNI
Amgen Inc., Sauzend Oaks, CA, USA		 FDA:
17 December 2020
EMA:
Not approved		 Chimeric mouse/human immunoglobulin G1 kappa (IgG1 κ) monoclonal antibody CD20 1 Intravenous Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia Infusion-related reactions, fever, lymphopenia, chills, infection, asthenia, neutropenia [207]
2 Tafasitamab-cxix MONJUVI
MorphoSys AG, Planegg, Germany 		FDA:
31 July 2020
EMA:
26 August 2021		 Humanized immunoglobulin G1/2 (IgG1/2) hybrid monoclonal antibody CD19 2 Intravenous Diffuse Large B-Cell Lymphoma Neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough,
pyrexia, peripheral edema, respiratory tract infection, decreased
appetite		 [199,225]
3 Daratumumab and hyaluronidase-fihj DARZALEX FASPRO
Janssen Pharmaceuticals, Inc., Belce, Belgium 		FDA:
1 May 2020
EMA:Not approved		 Humanized immunoglobulin G1 kappa (IgG1 κ) monoclonal antibody and an endoglycosidase CD38 3 Intravenous Multiple Myeloma Upper respiratory tracts infection, constipation, nausea, fatigue, pyrexia, peripheral sensory neuropathy, diarrhea, cough, insomnia, vomiting, back pain, muscle spasms, pneumonia, dyspnea [215,226]
4 Isatuximab SARCLISA Sanofi, Paris, France FDA:
2 March 2020
EMA:
30 May 2020		 Chimeric mouse/human immunoglobulin G1 kappa (IgG1 κ) monoclonal antibody CD38 3 Intravenous Multiple Myeloma Infusion reactions, upper respiratory tract infections, bronchitis, pneumonia [227,228]
5 Rituximab-pvvr RUXIENCE
Pfizer Inc., New York, NY, USA		 FDA:
23 July 2019
EMA:
1 April 2020		 Chimeric mouse/human immunoglobulin G1 kappa (IgG1 κ) monoclonal antibody CD20 1 Intravenous Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia Infusion-related reactions, fever, lymphopenia, chills, infection, asthenia, neutropenia [206,229]
6 Rituximab-abbs TRUXIMA Celltrion, Inc., Incheon, Korea FDA:
28 November 2018
EMA:
17 February 2017		 Chimeric mouse/human immunoglobulin G1 kappa (IgG1 κ) monoclonal antibody CD20 1 Intravenous Non-Hodgkin’s Lymphoma Infusion-related reactions, fever, lymphopenia, chills, infection, asthenia [230,231]
7 Mogamulizumab-kpkc POTELIGEO Kyowa Kirin, Inc., Bedminster, NJ, USA FDA:
8 August 2018
EMA:
22 November 2018		 Humanized immunoglobulin G1 kappa (IgG1 κ) monoclonal antibody CCR4 4 Intravenous Mycosis Fungoides, Sézary syndrome Rash, infusion related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection [232,233]
8 Elotuzumab EMPLICITI Bristol-Myers Squibb Company and AbbVie, Lake Bluff, IL, USA FDA:
30 November 2015
EMA:
11 May 2016		 Humanized immunoglobulin G1 (IgG1) monoclonal antibody SLAMF7 5 Intravenous Multiple Myeloma Fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, pneumonia [234,235]
9 Daratumumab DARZALEX Janssen Biotech, Inc., Horsham, PA, USA FDA:
16 November 2015
EMA:
20 May 2016		 Humanized immunoglobulin G1 kappa (IgG1 κ) monoclonal antibody CD38 3 Intravenous Multiple Myeloma Infusion-related reactions, lymphopenia, neutropenia, thrombocytopenia, anemia [236,237]
10 Nivolumab OPDIVO
Bristol-Myers Squibb Company, New York, NY, USA		 FDA:
22 December 2014
EMA:
19 June 2015		 Human immunoglobulin G4 kappa (IgG4 κ) monoclonal antibody PD-1 6 Intravenous Hodgkin’s Lymphoma Fatigue, upper respiratory tract infection, pyrexia, diarrhea, cough [238,239,240]
11 Pembrolizumab KEYTRUDA Merck, Kenilworth, NJ, USA FDA:
4 September 2014
EMA:
17 July 2015		 Humanized immunoglobulin G4 (IgG4) monoclonal antibody PD-1 6 Intravenous Primary Mediastinal Large B-Cell Lymphoma, Hodgkin’s Lymphoma Fatigue, cough, pruritus, nausea, rash, decreased appetite, constipation, arthralgia, diarrhea, anemia, hyperglycemia, hyponatremia, hypoalbuminemia, hypertriglyceridemia,, hypocalcaemia, elevated aspartate transaminase [241,242,243,244]
12 Obinutuzumab GAZYVA Genentech, Inc., South San Francisco, CA, USA FDA:
1 November 2013
EMA:
23 July 2014.		 Humanized immunoglobulin G1 (IgG1) monoclonal antibody CD20 1 Intravenous Chronic Lymphocytic Leukemia, Follicular Lymphoma Infusion reactions, neutropenia [245,246]

1 CD20: cluster of differentiation 20. 2 CD19: cluster of differentiation 19. 3 CD38: Cluster of differentiation 38. 4 CCR4: CC chemokine receptor 4. 5 SLAMF7: Signaling Lymphocyte Activation Molecule Family member 7. 6 PD-1: programmed death receptor-1.