The first approval of ADCs as a single agent by the Food and Drug Administration (FDA) and/or European Medicines Agency (EMA)
| Drug | Target | Indication | FDA/EMA | Approval year | Sponsor |
|---|---|---|---|---|---|
| Gemtuzumab ozogamicin | CD33 | AML | y/y | 2000; 2017 | Pfizer/Wyeth |
| Brentuximab vedotin | CD30 | HL | y/y | 2011 | Seattle Genetics |
| Trastuzumab emtansine | HER2 | HER2-positive mBC | y/y | 2013 | Genetech/Roche |
| Inotuzumab ozogamicin | CD22 | Acute lymphoblastic leukemia | y/y | 2017 | Pfizer/Wyeth |
| Moxetumomab pasudotox | CD22 | HCL | y/y–withdrawn | 2018–withdrawn in July 2023 | AstraZeneca |
| Enfortumab vedotin | Nectin-4 | Urothelial cancer | y/y | 2019 | Astellas/Seattle Genetics |
| Trastuzumab deruxtecan | HER2 | HER2-positive mBC | y/y | 2019 | AstraZeneca/Daiichi Sankyo |
| Sacituzumab govitecan | Trop-2 | Metastatic TNBC | y/y | 2020 | Immunomedics |
| Belantamab mafodotin | BCMA | Multiple myeloma | y/y–withdraw process | 2020–withdraw process in November 2022 | GlaxoSmithKline |
| Loncastuximab tesirine | CD19 | DLBCL | y/y | 2021 | ADC Therapeutics |
| Tisotumab vedotin-tftv | Tissue factor | Recurrent or metastatic cervical cancer | y/n | 2021 | Seagen Inc |
| Mirvetuximab soravtansine | FRα | FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer | y/y | 2022 | ImmunoGen |
ADCs: antibody-drug conjugates; AML: acute myeloid leukemia; HCL: hairy-cell leukemia; HL: Hodgkin lymphoma; HER2: human epidermal growth factor receptor 2; mBC: metastatic breast cancer; Nectin-4: nectin cell adhesion molecule 4; Trop-2: trophoblast cell surface antigen-2; TNBC: triple-negative breast cancer; BCMA: B cell maturation antigen; DLBCL: diffuse large B-cell lymphoma; FRα: folate receptor alpha; n: not; y: yes