Table 1.
Approved Bispecific Antibodies in Oncology.
S No. | NCT | N | Phase | Target | Therapy | Trade Name | Indication | Approval Date | Approved by |
---|---|---|---|---|---|---|---|---|---|
1 | NCT00836654 | 24 | I/II | CD3/EpCAM | Catumaxomab | Removab | Malignant Ascites | April 2009 | EMA |
2 | NCT01209286 | 36 | II | CD3/CD19 | Blinatumomab | Blincyto | Relapsed/Refractory B-cell ALL | December 2014 | FDA |
3 | NCT02609776 | 362 | I | MET/EGFR | Amivantamab | Rybrevant | EGFR Exon20ins NSCLC | May 2021 | FDA |
4 | NCT03070392 | 378 | II | CD3/TCR | Tebentafusp-tebn | Kimmtrak | Metastatic uveal melanoma | January 2022 | FDA |
5 | NCT02500407 | 238 | I/II | CD20/CD3 | Mosunetuzumab | Lunsumio | Relapsed/Refractory B-cell lymphoma | June 2022 | FDA |
6 | NCT04868708 | 45 | I | PD-1/CTLA-4 | Candonilimab | Recurrent/Metastatic cervical cancer | June 2022 | NMPA | |
7 |
NCT03145181 NCT04557098 |
165 | I/II | CD3/BCMA | Teclistamab-cqyv | Tecvayli | Relapsed/Refractory Multiple Myeloma | October 2022 | FDA |
8 | NCT03625037 | 148 | I/II | CD3/CD20 | Epcoritamab-bysp | Epkinly | Relapsed/Refractory DLBCL | May 2023 | FDA |
9 | NCT03075696 | 132 | I/II | CD3/CD20 | Glofitamab-gxbm | Columvi | Relapsed/Refractory DLBCL or large B-cell lymphoma | June 2023 | FDA |
10 | NCT04649359 | 97 | II | CD3/BCMA | Elranatamab-bcmm | Elrexfio | Relapsed/Refractory Multiple Myeloma | August 2023 | FDA |
Abbreviations: N—Number; CD—cluster of differentiation; cMet—C-mesenchymal-epithelial transition factor; CTLA-4—Cytotoxic T-Lymphocyte Antigen-4; EGFR—Epidermal Growth Factor Receptor; PD-1—programmed cell death 1; BCMA—B-cell maturation antigen; TCR—T-cell Receptor; EMA—European Medicines Agency; FDA—U.S. Food and Drug Administration; NMPA—National Medical Products Administration, DLBCL—diffuse large B-cell lymphoma; BCMA—B-cell maturation antigen.