Drug approvals · United States
FDA-approved antibody-drug conjugates
Every antibody-drug conjugate (ADC) with a current US approval, with its target, sponsor, original approval date and the FDA approval letter.
Not medical advice. This list records regulatory approvals. What each medicine is approved to treat, and for whom, is set out in its FDA label, linked on each row; treatment decisions belong with a qualified health professional.
15 antibody-drug conjugates, by approval date
A drug is listed when it has an approved US application in Drugs@FDA and its FDA label describes it as an antibody-drug conjugate, or as a target-directed antibody conjugated to a drug ("a HER2-directed antibody and topoisomerase inhibitor conjugate"). The date is the original approval of that application. Sort any column or download CSV.
| Drug (brand) | Target | First FDA approval | Application holder (as listed by FDA) | Application | Status | FDA label wording |
|---|---|---|---|---|---|---|
| Brentuximab vedotin (Adcetris) | CD30 | 19 Aug 2011 | SEATTLE GENETICS | BLA 125388 | Marketed | “ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of: • Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine ( 1.1 ).” Label, 11 Nov 2025 |
| Ado-trastuzumab emtansine (Kadcyla) | HER2 | 22 Feb 2013 | GENENTECH | BLA 125427 | Marketed | “KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for: the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.” Label, 1 Apr 2026 |
| Inotuzumab ozogamicin (Besponsa) | CD22 | 17 Aug 2017 | WYETH PHARMS INC | BLA 761040 | Marketed | “BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.” Label, 6 Feb 2026 |
| Gemtuzumab ozogamicin (Mylotarg) | CD33 | 1 Sep 2017 | WYETH PHARMS INC | BLA 761060 | Marketed | “MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for: • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older ( 1.1 ).” Label, 19 Dec 2025 |
| Polatuzumab vedotin (Polivy) | CD79b | 10 Jun 2019 | GENENTECH | BLA 761121 | Marketed | “POLIVY is a CD79b-directed antibody and microtubule inhibitor conjugate indicated: in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index …” Label, 24 Aug 2026 |
| Enfortumab vedotin (Padcev) | Nectin-4 | 18 Dec 2019 | ASTELLAS | BLA 761137 | Marketed | “PADCEV is a Nectin-4-directed antibody and microtubule inhibitor conjugate indicated: • in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle invasive bladder cancer (MIBC).” Label, 4 Aug 2026 |
| Fam-trastuzumab deruxtecan (Enhertu) | HER2 | 20 Dec 2019 | DAIICHI SANKYO | BLA 761139 | Marketed | “ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for: HER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and pertuzumab (THP).” Label, 15 May 2026 |
| Sacituzumab govitecan (Trodelvy) | Trop-2 | 22 Apr 2020 | IMMUNOMEDICS INC | BLA 761115 | Marketed | “TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated: Locally Advanced or Metastatic Triple-Negative Breast Cancer First Line As a single agent for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy.” Label, 24 Jun 2026 |
| Loncastuximab tesirine (Zynlonta) | CD19 | 23 Apr 2021 | ADC Therapeutics SA | BLA 761196 | Marketed | “ZYNLONTA is a CD19-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.” Label, 12 Jun 2026 |
| Tisotumab vedotin (Tivdak) | tissue factor | 20 Sep 2021 | SEAGEN | BLA 761208 | Marketed | “TIVDAK is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.” Label, 20 Nov 2025 |
| Mirvetuximab soravtansine (Elahere) | folate receptor alpha | 14 Nov 2022 | IMMUNOGEN INC | BLA 761310 | Marketed | “ELAHERE is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.” Label, 14 Jul 2025 |
| Datopotamab deruxtecan (Datroway) | Trop-2 | 17 Jan 2025 | DAIICHI SANKYO INC | BLA 761394 | Marketed | “DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.” Label, 27 May 2026 |
| Telisotuzumab vedotin (Emrelis) | c-Met | 14 May 2025 | ABBVIE INC | BLA 761384 | Marketed | “EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.” Label, 25 May 2025 |
| Belantamab mafodotin (Blenrep) | BCMA | 23 Oct 2025 | GLAXOSMITHKLINE LLC | BLA 761440 | Marketed | “BLENREP, a B‑cell maturation antigen (BCMA)‑directed antibody and microtubule inhibitor conjugate, is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.” Label, 23 Oct 2025 |
| Pivekimab sunirine (Decnupaz) | CD123 | 27 May 2026 | ABBVIE INC | BLA 761460 | Marketed | “DECNUPAZ is a CD123-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).” Label, 27 May 2026 |
Checked, not FDA-approved
Other antibody-drug conjugates we looked up that had no approved US application in Drugs@FDA on 4 October 2026: Sacituzumab tirumotecan, Patritumab deruxtecan, Ifinatamab deruxtecan, Trastuzumab rezetecan, Disitamab vedotin, Telisotuzumab adizutecan, Zilovertamab vedotin, Izalontamab brengitecan, Raludotatug deruxtecan. Some may be approved elsewhere, for example in China or the European Union; this list covers the United States only. Their trials are in the report Antibody-drug conjugates.
How this list is made
StatOrigin queries the FDA's openFDA service for Drugs@FDA applications and current drug labels. A drug is on the list only if it has an original new drug application or biologics licence application with approved status, and its FDA label describes it as an antibody-drug conjugate, or as a target-directed antibody conjugated to a drug ("a HER2-directed antibody and topoisomerase inhibitor conjugate") — the quoted wording on each row, from the current label. Each listed target appears in that label. The date is the original approval of the application listed; a drug approved earlier under a different application shows the current one. Separate applications for a new formulation of a listed drug (a subcutaneous version, for example) are not listed again. Approval letters and applications link to the FDA; labels link to DailyMed, the National Library of Medicine's copy of the FDA label. Approvals by other regulators are not shown. The list was last checked on 4 October 2026; report an error through the corrections page.
For trial activity behind these drugs — studies, phases and sponsors — see Antibody-drug conjugates.
Other lists: FDA-approved bispecific antibodies · FDA-approved KRAS inhibitors
Cite this list
StatOrigin. (2026). FDA-approved antibody-drug conjugates. https://statorigin.org/approved-drugs/antibody-drug-conjugates