ADC Approval up to 2021

ADC Approval up to 2021

Published by BroadPharm on July 21, 2021

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. Mylotarg (gemtuzumab ozogamicin) was firstly approved by the FDA in 2000. Mylotarg was pulled in 2010 due to safety concerns but was later approved at a lower recommended dose in 2017.

As of July 2021, the FDA has approved 11 different ADCs, which can be categorized into three generations, please refer to the article ADC Technology Review in 2021.

Table 1. The following list of ADCs that have been approved by the FDA as of July 2021.
DrugTrade nameMakerConditionApproval Year
Gemtuzumab ozogamicinMylotargPfizer/Wyethrelapsed acute myelogenous leukemia (AML)2000, 2017
Brentuximab vedotinAdcetrisSeattle Genetics, Millennium/Takedarelapsed HL and relapsed sALCL2011
Trastuzumab emtansineKadcylaGenentech, RocheHER2-positive metastatic breast cancer (mBC) 2013
Inotuzumab ozogamicinBesponsaPfizer/WyethCD22-positive B-cell precursor acute lymphoblastic leukemia2017
Moxetumomab pasudotoxLumoxitiAstrazenecahairy cell leukemia (HCL)2018
Polatuzumab vedotin-piiqPolivyGenentech, Rochediffuse large B-cell lymphoma (DLBCL)2019
Enfortumab vedotinPadcevAstellas/Seattle Geneticsurothelial cancer2019
Trastuzumab deruxtecanEnhertuAstraZeneca/Daiichi SankyoHER2-positive breast cancer2019
Sacituzumab govitecanTrodelvyImmunomedicstriple-negative breast cancer (mTNBC)2020
Belantamab mafodotin-blmfBlenrepGlaxoSmithKline (GSK)multiple myeloma2020
Loncastuximab tesirine-lpylZynlontaADC TherapeuticsLarge B-cell lymphoma2021

Two of the latest ADCs to be approved, Trodelvy and Zynlonta, were developed with PEG chains as part of their linker technology to improve solubility and stability in vivo.

As a worldwide leader of PEG linker tools, BroadPharm offers a wide array of different ADC Linkers to empower our customer's advanced research. These compounds feature great aqueous solubility, smart choice of PEG length, and a broad selection of functional groups to choose from.

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