ADC Approval up to 2023

ADC Approval up to 2023

Published by BroadPharm on October 27, 2023

Antibody-Drug Conjugates (ADCs) are a class of targeted drugs composed of a payload linked to an mAbs (antibody) that is designed to specifically release their payload at a tumor site.

The History of ADC Drugs Development began with the first ADC clinical trial in 1983. As of October, the FDA has approved 15 different ADCs as seen in Table 1.

Table 1. The following list of ADCs that have been approved by the FDA as of October 2023.

Drug

Trade name

Maker

Condition

Approval Year

Gemtuzumab ozogamicin

Mylotarg

Pfizer/Wyeth

relapsed acute myelogenous leukemia (AML)

2000, 2017

Brentuximab vedotin

Adcetris

Seattle Genetics, Millennium/Takeda

relapsed HL and relapsed sALCL

2011

Trastuzumab emtansine

Kadcyla

Genentech, Roche

HER2-positive metastatic breast cancer (mBC)

2013

Inotuzumab ozogamicin

Besponsa

Pfizer/Wyeth

CD22-positive B-cell precursor acute lymphoblastic leukemia

2017

Moxetumomab pasudotox

Lumoxiti

Astrazeneca

hairy cell leukemia (HCL)

2018

Polatuzumab vedotin-piiq

Polivy

Genentech, Roche

diffuse large B-cell lymphoma (DLBCL)

2019

Enfortumab vedotin

Padcev

Astellas/Seattle Genetics

urothelial cancer

2019

Trastuzumab deruxtecan

Enhertu

AstraZeneca/Daiichi Sankyo

HER2-positive breast cancer

2019

Sacituzumab govitecan

Trodelvy

Immunomedics

triple-negative breast cancer (mTNBC)

2020

Belantamab mafodotin-blmf

Blenrep

GlaxoSmithKline (GSK)

multiple myeloma

2020

Cetuximab saratolacan

Akalux

RakutenMedical

Head and neck cancer

2020

Loncastuximab tesirine-lpyl

Zynlonta

ADC Therapeutics

Large B-cell lymphoma

2021

Disitamab vedotin

Aidixi

RemeGen

HER2+ gastric carcinoma

2021

Tistotumab vedotin-tftv

Tivdak

Seagen

Cervical cancer

2021

Mirvetuximab soravtansine-gyxn

ELAHERE

ImmunoGen, Inc.

Ovarian Cancer

2022

Two of the latest ADCs to be approved, Tivdak and ELAHERETM were developed with linkers cleavable dipeptide val-cit and sulfo-SPDB linkers respectively.

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