Antibody-drug Conjugates (ADCs) - Approvals by FDA/EMA/NMPA/PMDA

In 2000, the launch of Mylotarg from Pfizer marked the debut of antibody drug conjugate (ADC), a complex that couples a cytotoxic small molecule drug to a monoclonal antibody via a rationally constructed linker to selectively deliver an effective cytotoxic drug into the tumor. During the eleven years between the initial launch of Mylotarg and its withdrawal in 2010, no new ADC drugs were marketed. However, in recent years, the pharmaceutical market has witnessed a new wave of ADC development.

Approved ADC Drugs

Up to 2022, there are 18 ADC drugs on the market worldwide (table 1). After the withdrawal of the first drug Mylotarg, the ADC drug market did not go into a lull. In 2011, Adcetris, an ADC drug developed by Seattle Genetics in collaboration with Takeda, was launched in the U.S. Kadcyla, an ADC drug developed by Roche's Genentech, was launched in the U.S. in 2013. Both ADC drugs have received good market repercussion. Below are details of the ADC drugs approved in each country.

Drug	Trade Name	Company	Approved Countries	1st Approval Date	Target	Linker	Paylaod	Indication
Gemtuzumab ozogamicin	Mylotarg®	Pfizer	FDA/EMA	May. 2000	CD33	cleavable	Calicheamicin	Acute Myeloid Leukemia (AML)
Brentuximab vedotin	Adcetris®	Seagen/Takeda	FDA/EMA/PMDA/NMPA	Aug. 2011	CD30	cleavable	MMAE	HL;sALCL;MF;DLBCL
Trastuzumab emtansine	Kadcyla®	Roche	FDA/EMA/PMDA/NMPA	Feb. 2013	HER2	non-cleavable	DM1	HER2+ BC
Inotuzumab ozogamicin	Besponsa®	Pfizer	FDA/EMA/PMDA/NMPA	Jun. 2017	CD22	cleavable	Calicheamicin	ALL
Moxetumomab pasudotox-tdfk	Lumoxiti®	AstraZeneca	FDA/PMDA	Sept. 2018	CD22	cleavable	PE38	HCL
Polatuzumab vedotin	Polivy®	Roche	FDA/EMA/PMDA/NMPA	Jun. 2019	CD79b	cleavable	MMAE	DLBCL
Enfortumab vedotin	Padcev®	Astellas/Seagen	FDA/EMA/NMPA/PMDA	Dec. 2019	Nectin-4	cleavable	MMAE	UC
Trastuzumab deruxtecan	Enhertu®	Daiichi Sankyo	FDA/EMA/PMDA/NMPA	Dec. 2019	HER2	cleavable	Dxd	HER2+ BC, HER2-Low/Ultralow MBC, HER2+ GC, NSCLC
Sacituzumab govitecan	Trodelvy®	Gilead	FDA/NMPA/EMA/PMDA	Apr. 2022	TROP2	cleavable	SN-38	HR+/HER2- MBC, TNBC
Belantamab mafodotin	Blenrep®	GSK	EMA/PMDA	Aug. 2020	BCMA	non-cleavable	MMAF	MM
Cetuximab sarotalocan	Akalux®	Rakuten Medical	PMDA	Sept. 2020 (Japan)	EGFR	Photoimmunotherapy	IRDye700DX	r/r Head and Neck Cancer
Loncastuximab tesirine	Zynlonta®	ADC Therapeutics	FDA/EMA/NMPA	Apr. 2021	CD19	cleavable	PBD SG3199	DLBCL
Disitamab vedotin	Aidixi®	RemeGen	NMPA	Jun. 2021 (China)	HER2	cleavable	MMAE	GC
Tisotumab vedotin	Tivdak®	Seagen	FDA/PMDA/EMA	Sept. 2021	TF	cleavable	MMAE	Cervical Cancer
Mirvetuximab soravtansine	ELAHERE™	ImmunoGen	FDA/EMA	Nov. 2022	FRα	cleavable	DM4	Ovarian Cancer
Sacituzumab tirumotecan	Jiataile®	Kelun-Biotech	NMPA	Nov. 2024 (China)	Trop-2	cleavable	Belotecan-derivative	EGFR-mutant NSCLC
Datopotamab Deruxtecan	Datroway	AstraZeneca/Daiichi Sankyo	PMDA/FDA/EMA	Dec. 2024	Trop-2	cleavable	Dxd	HR+/HER2– BC
Telisotuzumab vedotin	EMRELIS™	AbbVie	FDA	May. 2025	c-Met	cleavable	MMAE	NSCLC

Table 1: Global Approved ADCs. Two of the latest approved ADCs, Trodelvy and Zynlonta, were developed with PEG chains as part of their linker technology to improve solubility and stability in vivo.

USA FDA Approved ADCs: ADC drugs are available earlier in the U.S., with up to 15 drugs on the market and sales well ahead of other regions, including Mylotarg(2010), Adcetris(2011), Kadcyla(2013), Besponsa(2017), Lumoxiti (2018, permanently discontinue LUMOXITI from the US market in July 2023), Polivy(2019), Padcev(2019), Enhertu(2019), Trodelvy(2020), Zynlonta(2021), Tridak(2021), ELAHERE (2022), Datroway (2025) and EMRELIS (2025). From 2016 to 2020, the U.S. ADC market sales grow from $328 million to $1.47 billion, with a CAGR of 45%.

Europe EMA Approved ADCs: There are 13 ADC drugs on the market in Europe, including Adcetris(2012), Kadcyla(2013), Besponsa(2017), Mylotarg(2018), Blenrep(2020), Polivy(2020), Enhertu(2021), Trodelvy (2021), Padcev (2022), Zynlonta (2022), ELAHERE (2023), Tivdak (2025) and Datroway (2025), .

Japan PMDA Approved ADCs: A total of 12 ADC drugs are currently on the market in Japan, including Adcetris(2014), Kadcyla(2014), Besponsa (2018), Enhertu(2020), Akalux (2020), Padcev(2021), Lumoxiti (2021), Polivy (2021), Blenrep (2021),Tivdak (2023), Trodelvy (2024) and Datroway (2024),

China NMPA Approved ADCs: A total of 10 ADC drugs are currently on the market in China, including Adcetris (2020), Kadcyla (2020), Besponsa (2021), Aidixi (2021), Trodelvy (2022), Polivy (2023), Enhertu (2023), Padcev (2024), 佳泰莱 (2024) and Zynlonta (2024). The Chinese market has just seen a boom in ADC drugs.

Currently, the indications for ADC drugs are all focused on the oncology field. Among the 13 drugs that have been marketed, 6 drugs target solid tumors (breast cancer, bladder cancer, gastric cancer, etc.) and 7 drugs target hematologic tumors. Overview of ADC drug R&D layout, there is more R&D targeting solid tumors in the clinical trial stage. In contrast, the proportion of hematologic tumors has increased at the ready-to-market stage. Companies are also actively expanding the range of indications for ADCs, such as AbbVie's ABBV-3373, which is under development and has also shown promising clinical activity in clinical trials for the treatment of patients with rheumatoid arthritis. How to broaden the range of indications for ADC drugs will also be key to gaining market share for the drugs.

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References:
1. Nature Reviews Drug Discovery. The oncology market for antibody-drug conjugates.