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.

ADC Name

Structure

Maker

Disease

Payload

Payload Mechanism of Action

Target Antigen

mAb

Approval Year

Mirvetuximab soravtansine

ImmunoGen

Platinum-Resistant Ovarian Cancer

Maytansinoid DM4

Folate receptor alpha

FRα

IgG1

2022

Tisotumab vedotin-tftv

Seagen Inc

Recurrent or metastatic cervical cancer

MMAE/auristatin

Microtubule inhibitor

Tissue factor

IgG1

2021

Loncastuximab tesirine-lpyl

ADC Therapeutics

Large B-cell lymphoma

SG3199/PBD dimer

DNA cleavage

CD19

IgG1

2021

Belantamab mafodotin-blmf

GlaxoSmithKline

Adult patients with relapsed or refractory multiple myeloma

MMAF/auristatin

Microtubule inhibitor

BCMA

IgG1

2020; withdrawn Nov. 2022

Sacituzumab govitecan

Immunomedics

Adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for patients with relapsed or refractory metastatic disease

SN-38/camptothecin

TOP1 inhibitor

TROP2

IgG1

2020

Trastuzumab deruxtecan

AstraZeneca/Daiichi Sankyo

Adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens

DXd/camptothecin

TOP1 inhibitor

HER2

IgG1

2019

Enfortumab vedotin

Astellas/Seagen Genetics

Adult patients with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor, and a Pt-containing therapy

MMAE/auristatin

Microtubule inhibitor

Nectin4

IgG1

2019

Polatuzumab vedotin-piiq

Genentech, Roche

Relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL)

MMAE/auristatin

Microtubule inhibitor

CD79

IgG1

2019

Moxetumomab pasudotox

Astrazeneca

Adults with relapsed or refractory hairy cell leukemia (HCL)

PE38 (Pseudotox)

CD22

IgG1

2018

Gemtuzumab ozogamicin

Pfizer & Wyeth

Relapsed acute myelogenous leukemia (AML)

Ozogamicin/calicheamicin

DNA cleavage

CD33

IgG4

2017

Inotuzumab ozogamicin

Pfizer & Wyeth

Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia

Ozogamicin/calicheamicin

DNA cleavage

CD22

IgG4

2017

Trastuzumab emtansine

Genentech, Roche

HER2-positive metastatic breast cancer (mBC) following treatment with trastuzumab and a maytansinoid

DM1/maytansinoid

Microtubule inhibitor

HER2

IgG1

2013

Brentuximab vedotin

Seagen Genetics, Millennium & Takeda

Relapsed HL and relapsed sALCL

MMAE/auristatin

Microtubule inhibitor

CD30

IgG1

2011

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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