Table 1.
Commercially sponsored monoclonal antibody therapeutics granted first approvals in the European Union or United States during 2022. Table includes information publicly available as of November 18, 2022. Abbreviations: ADC, antibody–drug conjugate; BCMA, B cell maturation antigen; CTLA-4, Cytotoxic T-lymphocyte associated protein 4; EU, European Union; EUA, Emergency use authorization; FR, folate receptor; IgG, immunoglobulin; IL, interleukin; LAG-3, Lymphocyte-activation gene 3; NA, not applicable; PD-1, programmed cell death protein 1; PDUFA, Prescription Drug User Fee Act; RSV, Respiratory syncytial virus; SARS-CoV-2, Severe acute respiratory syndrome-coronavirus-2; VEGF, vascular endothelial growth factor.
| INN (Brand name) | Target; Format | Indication first approved | Date of first EU approval | Date of first US approval |
|---|---|---|---|---|
| Tebentafusp (Kimmtrak) | gp100, CD3; Bispecific immunoconjugate | Metastatic uveal melanoma | 4/1/2022 | 1/25/2022 |
| Faricimab (Vabysmo) | VEGF-A, Ang-2; Human/humanized IgG1 κ/λ bispecific | Diabetic macular edema and neovascular age-related macular degeneration | 9/15/2022 | 1/28/2022 |
| Sutimlimab (Enjaymo) | C1s; Humanized IgG4κ | Cold agglutinin disease | 11/15/2022 | 2/4/2022 |
| Relatlimab (Opdualag) | LAG-3; Human IgG4κ | Melanoma | 9/15/2022 | 3/18/2022 |
| Tixagevimab/cilgavimab (Evusheld) | SARS-CoV-2; Human IgG1κ | COVID-19 | 3/25/2022 | NA (EUA) |
| Mosunetuzumab (Lunsumio) | CD20, CD3; Humanized IgG1κ bispecific | Follicular lymphoma | 6/3/2022 | In review (PDUFA date 12/29/2022) |
| Teclistamab (TECVAYLI) | BCMA, CD3; Humanized/human IgG4λ bispecific | Multiple myeloma | 8/23/2022 | 10/25/2022 |
| Spesolimab (SPEVIGO) | IL-36 receptor; Humanized IgG1κ | Generalized pustular psoriasis | In review | 9/01/2022 |
| Tremelimumab (Imjudo; combo with durvalumab) | CTLA-4; Human IgG2κ | Hepatocellular carcinoma | In review | 10/21/2022 |
| Nirsevimab (Beyfortus) | RSV; Human IgG1κ | Prevention of RSV infection | 10/31/2022 | NA |
| Mirvetuximab soravtansine (ELAHERE™) | FRα; Humanized IgG1κ ADC | Ovarian cancer | NA | 11/14/2022 |
| Teplizumab (TZIELD) | CD3; Humanized IgG1κ | Delay of onset of Stage 3 Type 1 diabetes | NA | 11/17/2022 |