Therapeutic monoclonal antibodies approved by FDA in 2017

doi:10.15406/moji.2018.06.00198

MOJ

eISSN: 2373-4442

Immunology

Mini Review Volume 6 Issue 3

Therapeutic monoclonal antibodies approved by FDA in 2017

HenryHongrong Cai

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Pharmacovigilance and drug safety, EMD Serono and InVentive Health Clinical, USA

Correspondence: Henry Hongrong Cai, Ventive Health Clinical, 95 Cynthia Road Newton, MA 02459, USA, Tel 1-508-596-1348

Received: January 01, 1971 | Published: May 23, 2018

Citation: Cai HH. Therapeutic monoclonal antibodies approved by FDA in 2017. MOJ Immunol. 2018;6(3):82-84. DOI: 10.15406/moji.2018.06.00198

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Introduction

In 1975, Monoclonal antibody (mAb) technique was created by Georges Köhler, César Milstein, and Niels Kaj Jerne by using mouse x mouse hybridoma; they shared the Nobel Prize in Physiology or Medicine in 1984 for the discovery. 8 years later, in 1992 FDA approved first therapeutic mAb Muromonab-CD3 (trade name Orthoclone OKT3) to reduce acute rejection in patients with organ transplants, since then, as of May 10, 2018, FDA has approved 80 therapeutic mAbs.¹ Among them, in 2015, FDA totally approved 10 therapeutic monoclonal antibodies,² it is historical high since first approval in 1992; in 2016, once again FDA approved 10 therapeutic antibodies.³ In 2017 FDA broken the record and approved 17 therapeutic antibodies. This mini review focuses briefly on the characteristics of the antibodies approved in 2017 by FDA (Table 1) (Table 2).^4-20

Drug name	Active ingredients	Company	Approval date
SILIQ	BRODALUMAB	VALEANT LUXEMBOURG	2/15/2017
BAVENCIO	AVELUMAB	EMD SERONO INC	3/23/2017
OCREVUS	OCRELIZUMAB	GENENTECH INC	3/28/2017
DUPIXENT	DUPILUMAB	REGENERON PHARMACEUTICALS	3/28/2017
RENFLEXIS	INFLIXIMAB-ABDA	SAMSUNG BIOEPSIS CO LTD	4/21/2017
IMFINZI	DURVALUMAB	ASTRAZENECA UK LTD	05-01-17
BAVENCIO	AVELUMAB	EMD SERONO INC	05-09-17
KEVZARA	SARILUMAB	SANOFI SYNTHELABO	5/22/2017
RITUXAN HYCELA	HYALURONIDASE;RITUXIMAB	GENENTECH INC	6/22/2017
TREMFYA	GUSELKUMAB	JANSSEN BIOTECH	7/13/2017
BENLYSTA	BELIMUMAB	GLAXOSMITHKLINE LLC	7/20/2017
CYLTEZO	ADALIMUMAB-ADBM	BOEHRINGER INGELHEIM	8/25/2017
MYLOTARG	GEMTUZUMAB OZOGAMICIN	WYETH PHARMS INC	09-01-17
MVASI	BEVACIZUMAB-AWWB	AMGEN INC	9/14/2017
FASENRA	BENRALIZUMAB	ASTRAZENECA AB	11/14/2017
HEMLIBRA	EMICIZUMAB	GENENTECH INC	11/16/2017
OGIVRI	TRASTUZUMAB-DKST	MYLAN GMBH	12-01-17

Table 1 Therapeutic monoclonal antibodies approved by FDA in 2017

Drug name	Indications and usage	Warnings and precautions	Mechanism of action
SILIQ	moderate to severe plaque psoriasis	SUICIDAL IDEATION AND BEHAVIOR; Infection	IL-17RA antagonist
BAVENCIO	metastatic Merkel cell carcinoma (MCC).	Immune-mediated diseases	a programmed death ligand-1 (PD-L1) blocking antibody
OCREVUS	relapsing or primary progressive forms of multiple sclerosis	Infusion reactions; Infection; Malignancies	a CD20-directed cytolytic antibody
DUPIXENT	moderate-to-severe atopic dermatitis	Hypersensitivity; Conjunctivitis and Keratitis; Comorbid Asthma	interleukin-4 receptor alpha antagonist
RENFLEXIS	Crohn’s Disease; Ulcerative Colitis; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis	Increased risk of serious infections	tumor necrosis factor (TNF) blocker
IMFINZI	Locally advanced or metastatic urothelial carcinoma	Immune-mediated diseases	programmed death-ligand 1 (PD-L1) blocking antibody
BAVENCIO	metastatic Merkel cell carcinoma (MCC); locally advanced or metastatic urothelial carcinoma (UC)	Immune-mediated diseases	a programmed death ligand-1 (PD-L1) blocking antibody
KEVZARA	moderately to severely active rheumatoid arthritis	Serious Infections; Neutropenia; Gastrointestinal (GI) Perforation	interleukin-6 (IL-6) receptor antagonist
RITUXAN HYCELA	Follicular Lymphoma (FL); Diffuse Large B-cell Lymphoma (DLBCL); Chronic Lymphocytic Leukemia (CLL)	Severe mucocutaneous reactions; Tumor lysis syndrome; Hepatitis B virus reactivation; Progressive multifocal leukoencephalopathy resulting in death	CD20-directed cytolytic antibody, and hyaluronidase human, an endoglycosidase
TREMFYA	moderate-to-severe plaque psoriasis	Infections; Tuberculosis (TB)	interleukin-23 blocker
BENLYSTA	active, autoantibody-positive, systemic lupus erythematosus	Serious Infections; Progressive Multifocal Leukoencephalopathy (PML)	B-lymphocyte stimulator (BLyS)-specific inhibitor
CYLTEZO	Rheumatoid Arthritis (RA); Ankylosing Spondylitis (AS); Adult Crohn’s Disease (CD); Ulcerative Colitis (UC); Plaque Psoriasis (Ps)	Serious infections; Malignancies	biosimilar to HUMIRA (adalimumab TNF blocker)
MYLOTARG	newly-diagnosed CD33-positive acute myeloid leukemia (AML)	Hepatotoxicity; Hemorrhage; Embryo-fetal toxicity	CD33-directed antibody-drug conjugate
MVASI	Metastatic colorectal cancer; Non-squamous non-small cell lung cancer; Glioblastoma; Metastatic renal cell carcinoma; Cervical cancer	Perforation or Fistula; Hemorrhage	biosimilar to AVASTIN (bevacizumab, VEGF blocker)
FASENRA	maintenance treatment of patients with severe asthma aged 12 years and older	Hypersensitivity reactions; Reduction in Corticosteroid Dosage	interleukin-5 receptor alpha-directed mAb
HEMLIBRA	hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors	thrombotic microangiopathy and thrombotic events; Laboratory Coagulation Test Interference	bispecific factor IXa- and factor X-directed antibody
OGIVRI	HER2-overexpressing breast cancer; HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma	Cardiomyopathy; Infusion Reactions; Pulmonary Toxicity; Embryo-Fetal Toxicity; Exacerbation of Chemotherapy-Induced Neutropenia	biosimilar to HERCEPTIN (trastuzumab, HER2/neu receptor antagonist)