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Release date:2021/8/12 4:55:10

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 17 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.

Drugs (Company) Trade Names Target antigens Approved Countries First Approved Date Approved Indications
Hematological malignancies
Gemtuzumab ozogamicin (Pfizer) Mylotarg® CD33 FDA/EMA May. 2020 AML
Brentuximab vedotin (Seagen) Adcetris® CD30 FDA/EMA/PMDA/NMPA Aug. 2011 Hodgkin lymphoma (HL); anaplastic large cell lymphoma (ALCL); pcALCL
Inotuzumab ozogamicin (Pfizer) Besponsa® CD22 FDA/EMA/PMDA/NMPA Jun. 2017 R/R Acute Lymphoblastic Leukemia
Moxetumomab pasudotox (AstraZeneca) Lumoxiti® CD22 FDA/EMA/PMDA Sep. 2018 Hairy Cell Leukemia
Polatuzumab vedotin (Genentech) Polivy® CD79B FDA/EMA/PMDA/NMPA Jun. 2019 R/R DLBCL
Belantamab mafodotin (GSK) Blenrep® BCMA EMA/PMDA Aug. 2020 R/R MM (Withdrawn by FDA in 2022)
Loncastuximab tesirine (ADC Therapeutics) Zynlonta® CD19 FDA/EMA/NMPA Apr. 2021 DLBCL
Solid Tumors
Ado-trastuzumab emtansine (Genentech) Kadcyla® HER2 FDA/EMA/PMDA/NMPA Feb. 2013 HER2-positive early breast cancer
Enfortumab vedotin (Seagen) Padcev® Nectin-4 FDA/EMA/NMPA/PMDA Dec. 2019 locally advanced or metastatic urothelial cancer
Fam-trastuzumab deruxtecan (AstraZeneca/Daiichi Sankyo) Enhertu® HER2 FDA/EMA/PMDA/NMPA Dec. 2019 Breast Cancer, Gastric Cancer, Non-Small Cell Lung Cancer
Sacituzumab govitecan (Immunomedics) Trodelvy® Trop-2 FDA/NMPA/EMA/PMDA Apr. 2020 Breast Cancer, Urothelial Carcinoma
Cetuximab sarotalocan (Rakuten Medical) Akalux® EGFR PMDA Sep. 2020 unresectable locally advanced or recurrent HNSCC
Disitamab vedotin (RemeGen) Aidixi® HER2 NMPA Jun. 2021 locally advanced or metastatic gastric cancer
Tisotumab vedotin (Genmab/Seagen) Tivdak® TF FDA/PMDA Sep. 2021 recurrent or metastatic cervical cancer
Mirvetuximab soravtansine
(ImmunoGen)
ELAHERE™ FRα FDA/EMA Nov. 2022  epithelial ovarian, fallopian tube, or primary peritoneal cancer
Sacituzumab tirumotecan
(Kelun-Biotech)
佳泰莱 Trop-2 NMPA Nov. 2024 EGFR-mutant NSCLC
Datopotamab Deruxtecan
(AstraZeneca/Daiichi Sankyo)
Datroway  Trop-2 PMDA/FDA Dec. 2024 HR+/HER2– Breast Cancer

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 13 drugs on the market and sales well ahead of other regions, including Mylotarg(2010), Adcetris(2011), Kadcyla(2013), Besponsa(2017), Lumoxiti (2018), Polivy(2019), Padcev(2019), Enhertu(2019), Trodelvy(2020), Zynlonta(2021), Tridak(2021), ELAHERE (2022) and Datroway (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 12 ADC drugs on the market in Europe, including Adcetris(2012), Kadcyla(2013), Besponsa(2017), Mylotarg(2018), Blenrep(2020), Polivy(2020), Lumoxiti (2021), Enhertu(2021), Trodelvy (2021), Padcev (2022), Zynlonta (2022) and ELAHERE (2023).

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.

As a worldwide leader of PEG linker tools, Biopharma PEG 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.

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

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