FDA-Approved ADCs

FDA has approved 16 antibody–drug conjugates (ADCs) as of 2026, almost all in oncology, spanning both hematologic malignancies and solid tumors.

How Many and in What Areas

A 2026 review counts 16 FDA-approved ADCs, including first-wave agents (Mylotarg, Adcetris, Kadcyla) and newer approvals like Datroway (datopotamab deruxtecan), Emrelis (telisotuzumab vedotin), and Pivekimab sunirine (DECNUPAZ).

The portfolio covers acute leukemias, lymphomas, multiple myeloma, breast, ovarian, cervical, urothelial, and lung cancers, with essentially all approved ADCs still confined to oncology indications.

Snapshot Table of FDA-Approved ADCs (Core Facts)
ADC (Brand) Target Payload Class Linker Type First FDA Approval (key use)
Gemtuzumab ozogamicin (Mylotarg) CD33 Calicheamicin (DNA-damaging) Cleavable hydrazone 2000; reapproved 2017 for CD33+ AML
Brentuximab vedotin (Adcetris) CD30 MMAE (microtubule inhibitor) Cleavable Val-Cit 2011 for CD30+ lymphomas
Trastuzumab emtansine (Kadcyla) HER2 DM1 (microtubule inhibitor) Non-cleavable thioether 2013 for HER2+ metastatic breast cancer
Inotuzumab ozogamicin (Besponsa) CD22 Calicheamicin Cleavable 2017 for relapsed/refractory B-ALL
Polatuzumab vedotin (Polivy) CD79b MMAE Cleavable 2019 for relapsed/refractory DLBCL with BR regimen
Enfortumab vedotin (Padcev) Nectin-4 MMAE Cleavable 2019 for advanced urothelial cancer
Trastuzumab deruxtecan (Enhertu) HER2 DXd (topo I inhibitor) Cleavable peptide (GGFG) 2019 for HER2+ metastatic breast cancer; later HER2-low
Sacituzumab govitecan (Trodelvy) TROP-2 SN-38 (topo I inhibitor) Cleavable CL2A 2020 for metastatic TNBC (later expanded)
Belantamab mafodotin (Blenrep) BCMA MMAF (microtubule inhibitor) Non-cleavable 2020 for relapsed/refractory myeloma; withdrawn, reapproved 2025
Loncastuximab tesirine (Zynlonta) CD19 PBD dimer (DNA crosslinker) Cleavable 2021 for relapsed/refractory large B-cell lymphoma
Tisotumab vedotin (Tivdak) Tissue factor MMAE Cleavable 2021 for recurrent or metastatic cervical cancer
Mirvetuximab soravtansine (Elahere) FRα DM4 (microtubule inhibitor) Cleavable sulfo-SPDB 2022 for FRα+ platinum-resistant ovarian cancer
Datopotamab deruxtecan (Datroway) TROP-2 DXd (topo I inhibitor) Cleavable 2025 for HR+/HER2- metastatic breast cancer
Telisotuzumab vedotin (Emrelis) c-MET MMAE Cleavable Val-Cit 2025 for c-MET–overexpressing NSCLC
Pivekimab sunirine (DECNUPAZ) CD123 Alkylating agent (AA) Cleavable 2026 for blastic plasmacytoid dendritic cell neoplasm (BPDCN)
(Plus historical) Moxetumomab pasudotox (Lumoxiti) CD22 PE38 protein toxin Fusion/immunotoxin 2018 for hairy cell leukemia; later withdrawn from US market
High-Level Patterns

  • Payloads: Most approvals still use microtubule inhibitors (MMAE, DM1, DM4, MMAF) or DNA-interacting agents (calicheamicin, PBD), but topo I inhibitors (SN-38, DXd) now dominate the most recent, high-impact approvals like Enhertu and Datroway.

  • Linkers: Early ADCs split between cleavable (Mylotarg, Adcetris) and non-cleavable (Kadcyla), while virtually all newer ADCs use cleavable linkers to enable bystander killing and activity in antigen-heterogeneous tumors.

  • Indications: The portfolio has expanded from niche relapsed hematologic settings into earlier-line and broader solid tumor indications, especially breast, ovarian, and lung cancers, with Enhertu and Datroway as key drivers of this shift.

Reviews:

(1) Dumontet, C., Reichert, J. M., Senter, P. D., Lambert, J. M., & Beck, A. (2023). Antibody–drug conjugates come of age in oncology. In Nature Reviews Drug Discovery (Vol. 22, Issue 8, pp. 641–661). Nature Research. https://doi.org/10.1038/s41573-023-00709-2