MINI REVIEW

Therapeutic Monoclonal Antibodies Approved by

FDA in 2020
Henry Hongrong Cai, MD

Global Medical Service, Parexel International, Newton, Massachusetts, United States

ABSTRACT

This minireview summaries the major characters of 13 therapeutic monoclonal antibody appoved by FDA in year 2020.

Key words: FDA, therapeutic monoclonal antibody, target

INTRODUCTION the Nobel Prize in Physiology of Medicine in 1984 for the

discovery. Eight years later, in 1992, the US FDA approved

I
n 1975, the monoclonal antibody (mAb) technique was the first therapeutic mAb muromonab-CD3 (trade name
created by Georges Köhler, César Milstein, and Niels Kaj Orthoclone OKT3) to reduce acute rejection in patients with
Jerne using a mouse x mouse hybridoma. They shared organ transplants. Since then, as of December 31, 2020,

Table 1: Therapeutic monoclonal antibodies approved by FDA in 2020

Drug name Active ingredients Company Approval date
TEPEZZ Teprotumumab-trb HORIZON THERAPEUTICS January 21, 2020
VYEPTI Eptinezumab-jjmr Lundbeck February 21, 2020
SARCLISA Isatuximab-irfc SANOFI AVENTIS March 2, 2020
TRODELVY Sacituzumab govitecan-hziy IMMUNOMEDICS April 22, 2020
DARZALEX FASPRO Daratumumab and JANSSEN May 1, 2020
hyaluronidase-fihj
UPLIZNA Inebilizumab-cdon VIELA June 11, 2020
PHESGO Pertuzumab, trastuzumab, and GENENTECH June 29, 2020
hyaluronidase-zzxf
BLENREP Belantamab mafodotin-blmf GLAXOSMITHKLINE August 5, 2020
ENSPRYNG Satralizumab-mwge GENENTECH August 14, 2020
INMAZEB ATOLTIVIMAB +2 REGENERON October 14, 2020
DANYELZA NAXITAMAB-GQGK Y-MABS THERAPEUTICS November 25, 2020
MARGENZA MARGETUXIMAB-CMKB MACROGENICS December 16, 2020
RIABNI RITUXIMAB-ARRX AMGEN December 17, 2020
ATOLTIVIMAB +2 ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB

Address for correspondence:

Henry Hongrong Cai, MD, Global Medical Service, Parexel International, 275 Grove Street, Newton, Massachusetts,
United States.
https://doi.org/10.33309/2639-8583.040101 www.asclepiusopen.com
© 2021 The Author(s). This open access article is distributed under a Creative Commons Attribution (CC-BY) 4.0 license.

Clinical Research in Immunology  •  Vol 4  •  Issue 1  •  2021 1

 Cai: FDA approved mAb in 2020

Table 2: Some characteristics of the therapeutic Mab approved by FDA in 2020

Drug name Indications and usage Warnings and precautions Mechanism of action
TEPEZZ Thyroid eye disease IBD worsening; hyperglycemia IGF-1R block
VYEPTI Migraine Hypersensitivity CGRP block
SARCLISA Multiple myeloma Neutropenia; SPM Anti-CD38, ADCC, CDC,
TRODELVY mTNBC Hypersensitivity, neutropenia Anti-Trop-2; SN-38; ADC
DARZALEX FASPRO Multiple myeloma Hypersensitivity, Neutropenia Anti-CD38, ADCC, CDC,
UPLIZNA NMOSD (AQP4+) Immune compromise Anti-CD19
PHESGO Breast cancer (HER2+) Neutropenia Anti-HER2; increases permeability
BLENREP Multiple Myeloma Thrombocytopenia Anti-BCMA; microtubule inhibitor;
ADC
ENSPRYNG NMOSD (AQP4+) Elevated liver enzymes Anti-IL6 receptor
INMAZEB Zaire ebolavirus Hypersensitivity Zaire ebolavirus glycoprotein
infection.
DANYELZA Neuroblastoma Neurotoxicity; Hypertension Anti-glycolipid GD2, CDC, ADCC
MARGENZA Breast cancer Left ventricular dysfunction Anti-HER2, ADCC
RIABNI NHL, CLL, GPA, MPA IRR; TLS; PML Anti-CD20, ADCC, CDC
IBD: Inflammatory bowel disease, IGF-1R: Insulin-like growth factor 1 (IGF-1) receptor, CGRP: Calcitonin gene-related peptide,
SPM: Second primary malignancies, ADCC: Antibody-dependent cell-mediated cytotoxicity, CDC: Complement-dependent cytotoxicity,
ADCP: Antibody-dependent cellular phagocytosis, mTNBC: Metastatic triple-negative breast cancer, SN-38: Topoisomerase I inhibitor,
ADC: Antibody drug conjugate, NMOSD: Neuromyelitis optica spectrum disorder, AQP4+: Anti-aquaporin-4 antibody positive, NHL: Non-
Hodgkin’s lymphoma, CLL: Chronic lymphocytic leukemia, GPA: Granulomatosis with polyangiitis (Wegener’s granulomatosis), MPA:
Microscopic polyangiitis, IRR: Infusion-related reaction, TLS: Tumor lysis syndrome, PML: Progressive multifocal leukoencephalopathy

FDA has approved 119 therapeutic mAbs (including two drugsatfda_docs/label/2020/761143s000lbl.pdf.

diagnostic mAb).[1] Among them, in 2015, FDA approved 8. Available from: https://www.accessdata.fda.gov/drugsatfda_
10 therapeutic monoclonal antibodies;[2] it was a historic docs/label/2020/761119s000lbl.pdf.
high since the first approval in 1992. In 2016, once again 9. Available from: https://www.accessdata.fda.gov/drugsatfda_
FDA approved 10 therapeutic antibodies.[3] In 2017, FDA docs/label/2020/761113s000lbl.pdf.
10. Available from: https://www.accessdata.fda.gov/drugsatfda_
broke its record and approved 17 therapeutic antibodies.[4]
docs/label/2020/761115s000lbl.pdf.
In 2018, FDA approved 15 therapeutic antibodies.[5] In 2019,
11. Available from: https://www.accessdata.fda.gov/drugsatfda_
FDA approved 16 therapeutic antibodies.[6] In 2020, despite docs/label/2021/761145s002lbl.pdf.
the impact of COVID 19 pandemic, FDA approved 13 12. Available from: https://www.accessdata.fda.gov/drugsatfda_
therapeutic antibodies. This mini-review focuses briefly on docs/label/2020/761142s000lbl.pdf.
the characteristics of 13 therapeutic antibodies approved in 13. Available from: https://www.accessdata.fda.gov/drugsatfda_
2020 by FDA [Tables 1 and 2].[7-19] docs/label/2020/761170s000lbl.pdf.
14. Available from: https://www.accessdata.fda.gov/drugsatfda_
docs/label/2020/761158s000lbl.pdf.
REFERENCES 15. Available from: https://www.accessdata.fda.gov/drugsatfda_
docs/label/2020/761149s000lbl.pdf.
1. Cai HH. Risk evaluation and mitigation strategy for approved
16. Available from: https://www.accessdata.fda.gov/drugsatfda_
therapeutic antibodies. MOJ Immunol 2014;1:28.
docs/label/2020/761169s000lbl.pdf.
2. Cai HH. Therapeutic monoclonal antibodies approved by FDA
17. Available from: https://www.accessdata.fda.gov/drugsatfda_
in 2015. MOJ Immunol 2016;3:87.
docs/label/2020/761171lbl.pdf.
3. Cai HH. Therapeutic monoclonal antibodies approved by FDA
18. Available from: https://www.accessdata.fda.gov/drugsatfda_
in 2016. MOJ Immunol 2017;5:145.
docs/label/2020/761150s000lbl.pdf.
4. Cai HH. Therapeutic monoclonal antibodies approved by FDA
19. Available from: https://www.accessdata.fda.gov/drugsatfda_
in 2017. MOJ Immunol 2018;6:82-4.
docs/label/2020/761140s000lbl.pdf.
5. Cai HH, Kivel N. Therapeutic monoclonal antibodies approved
by food and drug administration in 2018. Clin Res Immunol
2019;2:1-3. How to cite this article: Cai HH. Therapeutic Monoclonal
6. Cai HH. Therapeutic monoclonal antibodies approved by FDA Antibodies Approved by FDA in 2020. Clin Res Immunol
in 2019. Clin Res Immunol 2020;3:1-2.
2021;4(1):1-2.
7. Available from: https://www.accessdata.fda.gov/

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