Monoclonal Antibodies for Cancer Therapy Approved by FDA

Cai, Henry Hongrong

doi:10.15406/moji.2016.04.00120

Cited by 6 publications

(5 citation statements)

References 1 publication

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“…Nivolumab (Opdivo ® ) [ 17 ], as an anti-PD-1 mAb, was approved for metastatic lung squamous cell carcinoma in 2014 by the FDA. The other FDA-approved mAbs for cancers were launched to market [ 55 , 56 ]. Particularly, in the 2020s, four mAbs were approved by the FDA ( Table 1 ) [ 18 ]: (i) isatuximab (Sarclisa ® ) against CD38 for multiple myeloma in 2020, (ii) tafasitamab (Monjuvi ® ) against CD19 for diffuse large B cell lymphoma in 2020, (iii) naxitamab (Danyelza ® ) against GD2 for high-risk neuroblastoma and refractory osteomedullary disease in 2020, and (iv) dostarlimab (Jemperli ® ) against PD-1 for endometrial cancer in 2021.…”

Section: Discussionmentioning

confidence: 99%

Delivery of Drugs into Cancer Cells Using Antibody–Drug Conjugates Based on Receptor-Mediated Endocytosis and the Enhanced Permeability and Retention Effect

Tashima

2022

Antibodies

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Innumerable people worldwide die of cancer every year, although pharmaceutical therapy has actualized many benefits in human health. For background, anti-cancer drug development is difficult due to the multifactorial pathogenesis and complicated pathology of cancers. Cancer cells excrete hydrophobic low-molecular anti-cancer drugs by overexpressed efflux transporters such as multiple drug resistance 1 (MDR1) at the apical membrane. Mutation-driven drug resistance is also developed in cancer. Moreover, the poor distribution of drug to cancer cells is a serious problem, because patients suffer from off-target side effects. Thus, highly selective and effective drug delivery into solid cancer cells across the membrane should be established. It is known that substances (10–100 nm in diameter) such as monoclonal antibodies (mAbs) (approximately 14.2 nm in diameter) or nanoparticles spontaneously gather in solid tumor stroma or parenchyma through the capillary endothelial fenestration, ranging from 200–2000 nm, in neovasculatures due to the enhanced permeability and retention (EPR) effect. Furthermore, cancer antigens, such as HER2, Nectin-4, or TROP2, highly selectively expressed on the surface of cancer cells act as a receptor for receptor-mediated endocytosis (RME) using mAbs against such antigens. Thus, antibody–drug conjugates (ADCs) are promising anti-cancer pharmaceutical agents that fulfill accurate distribution due to the EPR effect and due to antibody–antigen binding and membrane permeability owing to RME. In this review, I introduce the implementation and possibility of highly selective anti-cancer drug delivery into solid cancer cells based on the EPR effect and RME using anti-cancer antigens ADCs with payloads through suitable linkers.

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Section: Discussionmentioning

confidence: 99%

Delivery of Drugs into Cancer Cells Using Antibody–Drug Conjugates Based on Receptor-Mediated Endocytosis and the Enhanced Permeability and Retention Effect

Tashima

2022

Antibodies

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“…mAbs are very important in the immunotherapy of different types of cancers [34]. However, the patent rights of some currently used mAbs have already expired [35,36] while those of others will expire in near future [37].…”

Section: Strategy For Cleia Developmentmentioning

confidence: 99%

A Novel Highly Sensitive Chemiluminescence Enzyme Immunoassay with Signal Enhancement Using Horseradish Peroxidase-Luminol-Hydrogen Peroxide Reaction for the Quantitation of Monoclonal Antibodies Used for Cancer Immunotherapy

2023

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The development and validation of a novel enhanced chemiluminescence enzyme immunoassay (CLEIA) with excellent sensitivity for the quantification of monoclonal antibodies (mAbs) used for immunotherapy of cancer are described in this paper for the first time. The 96-microwell plates were used for the assay procedures, which involved the non-competitive binding reaction to a specific antigen. The immune complex of the antigen-mAb formed on the internal surface of the plate wells was quantified by a novel chemiluminescence (CL)-producing horseradish peroxidase (HRP) reaction. The reaction employed 4-(imidazol-1-yl)phenol (IMP) as a highly potent signal enhancer for the HRP-luminol–hydrogen peroxide (H2O2) CL reaction. The proposed CLEIA was developed for bevacizumab (BEV), as a representative example for mAbs. The CLEIA was validated in accordance with the immunoassay validation for bioanalysis standards, and all of the validation criteria were met. The assay’s limit of detection (LOD) and limit of quantitation (LOQ) were 9.3 and 28.2 pg mL−1, respectively, with a working dynamic range of 10–400 pg mL−1. The assay enables the accurate and precise quantitation of mAbs in human plasma samples without any interference from endogenous substances and/or plasma matrix. The novel CLEIA was compared in terms of dynamic range and sensitivity with other pre-validated enzyme-linked immunosorbent assay (ELISA) using HRP/colorimetric substrate as a detection system and the observed differences were explained. The CLEIA protocol’s ease of use, high throughput, and simplicity allows to analyze numerous samples in clinical settings. The proposed CLEIA has a significant benefit in the assessment of mAbs in clinical settings for the evaluation of their pharmacokinetics, pharmacodynamics, therapeutic drug monitoring, and refining their safety profiles, opening a new era for a better understanding of pharmacodynamics at the cellular level.

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“…Eight years later, in 1992 US FDA approved the first therapeutic mAb muromonab-CD3 (trade name Orthoclone OKT3) to reduce acute rejection in patients with organ transplants. In 1997 US FDA approved first therapeutic mAb rituximab (trade name RITUXAN) for treatment of NHL and CLL [1,2]. Since then, as of December 15, 2022, FDA has approved 151 therapeutic mAbs, 58 were approved for cancer therapy, among them 20 targets at hematological malignancies, listed here [3-22].…”

Section: Issn: 2475-6296mentioning

confidence: 99%

Untitled

2023

JCEI

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Monoclonal Antibodies for Cancer Therapy Approved by FDA

Cited by 6 publications

References 1 publication

Delivery of Drugs into Cancer Cells Using Antibody–Drug Conjugates Based on Receptor-Mediated Endocytosis and the Enhanced Permeability and Retention Effect

Delivery of Drugs into Cancer Cells Using Antibody–Drug Conjugates Based on Receptor-Mediated Endocytosis and the Enhanced Permeability and Retention Effect

A Novel Highly Sensitive Chemiluminescence Enzyme Immunoassay with Signal Enhancement Using Horseradish Peroxidase-Luminol-Hydrogen Peroxide Reaction for the Quantitation of Monoclonal Antibodies Used for Cancer Immunotherapy

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