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.
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
Loncastuximab tesirine-lpyl Zynlonta ADC Therapeutics Large B-cell lymphoma 2021

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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