Drug approvals · United States
FDA-approved bispecific antibodies
Every bispecific antibody and bispecific T-cell engager with a current US approval, in cancer and beyond, with both targets, the sponsor, the 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 bispecifics, by approval date
A drug is listed when it has an approved US application in Drugs@FDA and its FDA label describes it as bispecific (a bispecific antibody or a bispecific T-cell engager). The date is the original approval of that application. Sort any column or download CSV.
| Drug (brand) | Targets | First FDA approval | Application holder (as listed by FDA) | Application | Status | FDA label wording |
|---|---|---|---|---|---|---|
| Blinatumomab (Blincyto) | CD19 × CD3 | 3 Dec 2014 | AMGEN | BLA 125557 | Marketed | “Blinatumomab is a bispecific CD19-directed CD3 T-cell engager.” Label, 14 Apr 2026 |
| Emicizumab (Hemlibra) | factor IXa × factor X | 16 Nov 2017 | GENENTECH INC | BLA 761083 | Marketed | “Emicizumab-kxwh is a humanized monoclonal modified immunoglobulin G4 (IgG4) bispecific antibody binding factor IXa and factor X.” Label, 11 Jul 2025 |
| Amivantamab (Rybrevant, Rybrevant Faspro) | EGFR × MET | 21 May 2021 | JANSSEN BIOTECH | BLA 761210 | Marketed | “Amivantamab-vmjw is a low-fucose human immunoglobulin G1-based bispecific antibody directed against the EGF and MET receptors, produced by mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology that has a molecular weight of approximately 148 kDa.” Label, 11 Nov 2025 |
| Tebentafusp (Kimmtrak) | gp100 × CD3 | 25 Jan 2022 | IMMUNOCORE LTD | BLA 761228 | Marketed | “Tebentafusp-tebn is a bispecific gp100 peptide-HLA-directed T cell receptor CD3 T cell engager.” Label, 20 Aug 2026 |
| Faricimab (Vabysmo) | Ang-2 × VEGF-A | 28 Jan 2022 | GENENTECH INC | BLA 761235 | Marketed | “Faricimab-svoa is a humanized bispecific immunoglobulin G1 (IgG1) antibody that binds both vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2).” Label, 15 Apr 2026 |
| Teclistamab (Tecvayli) | BCMA × CD3 | 25 Oct 2022 | JANSSEN BIOTECH | BLA 761291 | Marketed | “Teclistamab-cqyv, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a humanized immunoglobulin G4-proline, alanine, alanine (IgG4-PAA) antibody.” Label, 10 Mar 2026 |
| Mosunetuzumab (Lunsumio) | CD20 × CD3 | 22 Dec 2022 | GENENTECH INC | BLA 761263 | Marketed | “Mosunetuzumab-axgb is a bispecific CD20-directed CD3 T-cell engager.” Label, 29 Jun 2026 |
| Epcoritamab (Epkinly) | CD20 × CD3 | 19 May 2023 | GENMAB US, INC. | BLA 761324 | Marketed | “Epcoritamab-bysp is a bispecific CD20-directed CD3 T-cell engager; it is a humanized bispecific IgG1 antibody.” Label, 22 Jun 2026 |
| Glofitamab (Columvi) | CD20 × CD3 | 15 Jun 2023 | GENENTECH INC | BLA 761309 | Marketed | “Glofitamab-gxbm is a bispecific CD20-directed CD3 T-cell engager.” Label, 25 Jun 2026 |
| Talquetamab (Talvey) | GPRC5D × CD3 | 9 Aug 2023 | JANSSEN BIOTECH | BLA 761342 | Marketed | “Talquetamab-tgvs is a bispecific GPRC5D-directed CD3 T-cell engager.” Label, 8 Oct 2025 |
| Elranatamab (Elrexfio) | BCMA × CD3 | 14 Aug 2023 | PFIZER INC | BLA 761345 | Marketed | “Elranatamab-bcmm is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager.” Label, 14 May 2026 |
| Tarlatamab (Imdelltra) | DLL3 × CD3 | 16 May 2024 | AMGEN INC | BLA 761344 | Marketed | “Tarlatamab-dlle is a bispecific DLL3-directed CD3 T-cell engager that binds to DLL3 expressed on the surface of cells, including tumor cells, and CD3 expressed on the surface of T cells.” Label, 23 Jun 2026 |
| Zanidatamab (Ziihera) | HER2 | 20 Nov 2024 | JAZZ PHARMS | BLA 761416 | Marketed | “Zanidatamab‑hrii is a humanized, IgG1-like, bispecific HER2-directed antibody.” Label, 24 Aug 2026 |
| Zenocutuzumab (Bizengri) | HER2 × HER3 | 4 Dec 2024 | MERUS N.V. | BLA 761352 | Marketed | “Zenocutuzumab-zbco is a low-fucose humanized full-length immunoglobulin G1 (IgG1) bispecific HER2- and HER3-directed antibody.” Label, 19 May 2026 |
| Linvoseltamab (Lynozyfic) | BCMA × CD3 | 2 Jul 2025 | RENGENERON PHARMACEUTICALS, INC. | BLA 761400 | Marketed | “Linvoseltamab-gcpt, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a recombinant human immunoglobulin (Ig)G4 antibody.” Label, 2 Jul 2025 |
Checked, not FDA-approved
Other bispecifics we looked up that had no approved US application in Drugs@FDA on 4 October 2026: Odronextamab, Ivonescimab, Cadonilimab, Catumaxomab, Izalontamab brengitecan. 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 Oncology bispecific antibodies.
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 bispecific (a bispecific antibody or a bispecific T-cell engager) — 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 Oncology bispecific antibodies.
Other lists: FDA-approved antibody-drug conjugates · FDA-approved KRAS inhibitors
Cite this list
StatOrigin. (2026). FDA-approved bispecific antibodies. https://statorigin.org/approved-drugs/bispecific-antibodies