MOJ ISSN: 2373-4442MOJI

Immunology
Letter to Editor
Volume 4 Issue 2 - 2016
Monoclonal Antibodies for Cancer Therapy Approved by FDA
Xiangfan Chen1 and Henry Hongrong Cai2*
1Nantong University, School of Pharmacy, China
2Medical Director, Pharmacovigilance and Drug Safety, USA
Received: October 12, 2016 | Published: October 17, 2016
*Corresponding author: Henry Hongrong Cai, Medical Director, Pharmacovigilance and Drug Safety, inVentiv Health Clinical, 95 Cynthia Road Newton, MA 02459, USA, Tel: 617-584-6628; Email:
Citation: Chen X, Cai HH (2016) Monoclonal Antibodies for Cancer Therapy Approved by FDA. MOJ Immunol 4(2): 00120. DOI: 10.15406/moji.2016.04.00120

Keywords

Monoclonal antibodies; Cancer; mAb; FDA

Abbreviations

mAb: Monoclonal Antibody; CDC: Complement-Dependent Cytotoxicity; TSA: Tumor Specific Antigen; ADCC: Antibody-Dependent Cell Mediated Cytotoxicity

Letter to Editor

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 October, 2016; FDA has approved 65 therapeutic mAbs [1-3]. Among them 23 were approved for treatment of cancers [4-26]. These therapeutic mAb targets at components expressed on cancer cell, possible mechanisms of cell Iysis include complement-dependent cytotoxicity (CDC), antibody-dependent cell mediated cytotoxicity (ADCC), induced apoptosis, cancer cell growth inhibition, direct cytoxicities, and conjugates indirect effect resulting cancer cell death (radiation or internalized derives). Unfortunately, so far there is no tumor specific antigen (TSA) available for target, those antigen chosen as target, they also expressed at normal cells, which inevitably causes various adverse reactions (discussed in another article), that probably one of the reasons why the efficacy is far from ideal, even the therapy only stops the cancer progression for 1.5 months at beginning, until now, approved May 18, this year, for 5.7 months [26], [Table 1].

CD cluster of differentiation

EGF epidermal growth factor

VEGFR vascular endothelial growth factor receptor

VEGF vascular endothelial growth factor

EGFR epidermal growth factor receptor

epidermal growth factor receptor

CTLA-4 cytotoxic T-lymphocyte-associated protein 4

HER2 human epidermal growth factor receptor 2

PD-1 Programmed cell death protein 1

GD2 glycolipid disialoganglioside

SLAMF7 Signaling Lymphocytic Activation Molecule Family member 7

PD-L1 Programmed death-ligand 1

B-NHL B-cell non-Hodgkin's lymphoma

AML acute myeloid leukemia

B-CLL B-cell chronic lymphocytic leukemia

MCC metastatic colorectal carcinoma

HL Hodgkin's lymphoma

ALL acute lymphocytic leukemia

MM multiple myeloma

Drug Name

Approval Date

Company

Active Integedients

Target

Indication

Rituxan

11/26/1997

IDEC

Rituximab

CD20

B-NHL

Herceptin

9/25/1998

Genetech

Trastuzumab

EGF

Breast Ca

Mylotarg

5/17/2000

Wyeth

Gemtuzumab Ozogamicin

CD33

AML

Campath

2/7/2001

Genzyme

Alemtuzumab

CD52

B-CLL

Zevalin

2/19/2002

Spectrum

Ibritumomab Tiuxetan

CD20

B-NHL

Erbitux

2/12/2004

Imclone

Cetuximab

VEGFR

MCC

Avastin

2/26/2004

Genetech

Bevacizumab

VEGF

Colon Ca

Vectibix

9/27/2006

Amgen

Panitumumab

EGFR

Colorectal Ca

Arzera

10/26/2009

Glaxo

Ofatumumab

CD20

B-CLL

Yervoy

3/25/2011

BMS

Ipilimumab

CTLA-4

Melanoma

Adcetris

8/19/2011

Seattle Sci

Brentuximab Vedotin

CD30

HL

Perjeta

6/8/2012

Genetech

Pertuzumab

HER2

Breast Ca

Kadcyla

2/22/2013

Genetech

Ado-Trastuzumab Emtansine

HER2

Breast Ca

Gazyva

11/1/2013

Genetech

Obinutuzumab

CD20

B-CLL

Cyramza

4/21/2014

Eli Eilly

Ramucirumab

VEGFR2

Gastric Ca

Ketruda

9/4/2014

MSD

Pembrolizumab

PD-1

Melanoma

Bexxar

12/3/2014

Amgen

Tositumomab;                 Iodine I 131 Tositumomab

CD19+CD3

ALL

Opdivo

12/22/2014

BMS

Nivolumab

PD-1

Melanoma

Unituxin

3/10/2015

United Terap

Dinutuximab

GD2

Neuroblastoma

Darzalex

11/16/2015

Janssen

Daratumumab

CD38

MM

Portrazza

11/24/2015

Eli Eilly

Necitumumab

EGFR

Lung cancer

Empliciti

11/30/2015

BMS

Elotuzumab

SLAMF7

MM

Tecentiq

5/18/2016

Genetech

Atezolizumab

PD-L1

Urothelial Ca

Table 1: Monoclonal Antibodies for Cancer Therapy Approved By FDA.

References

  1. Cai HH (2016) Therapeutic Monoclonal Antibodies Approved by FDA in 2015. MOJ Immunology 3(2): 87.
  2. Cai HH (2014) Molecular Pharmacovigilance: Safety Signal for Drug Modification, MOJ Immunology 1(5): 25.
  3. Cai HH (2014) Risk Evaluation and Mitigation Strategy for Approved Therapeutic Antibodies. MOJ Immunology 1(5): 28.
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  26. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761034Orig1s000lbl.pdf
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