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Belantamab mafodotin (GSK) | Blenrep® | BCMA | EMA/PMDA | Aug. 2020 | R/R MM (Withdrawn by FDA in 2022) |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.
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References:
1. Nature Reviews Drug Discovery. The oncology market for antibody-drug conjugates.
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