Table 3.
Commercially sponsored investigational monoclonal antibody therapeutics in regulatory review in the European Union or United States. Table includes information publicly available as of November 18, 2022. Abbreviations: ADC, antibody–drug conjugate; CNS, central nervous system; CRL, complete response letter; HER2, human epidermal growth factor receptor 2; IL, interleukin; MASP, mannan-binding lectin-associated serine protease; NA, Not applicable or available; PD-1, programmed cell death protein 1; PDUFA, Prescription Drug User Fee Act.
| International non- proprietary name | Target; Format | Indication(s) under review | Status in EU | Status in US (estimated decision date) |
|---|---|---|---|---|
| Toripalimab | PD-1; Humanized IgG4κ | Nasopharyngeal carcinoma, esophageal squamous cell carcinoma | In review | In review (PDUFA date 12/23/2022) |
| Ublituximab | CD20; Chimeric IgG1κ | Multiple sclerosis | In review | In review (PDUFA date 12/28/2022) |
| Lecanemab | Amyloid beta protofibrils; Humanized IgG1κ | Early Alzheimer’s disease | NA | In review (PDUFA date 1/6/2023) |
| Trastuzumab duocarmazine | HER2; Humanized IgG1κ ADC |
HER2+ unresectable locally advanced or metastatic breast cancer | In review | In review (PDUFA date 5/12/2023) |
| Mirikizumab | IL-23p19; Humanized IgG4ҡ | Ulcerative colitis | In review | In review (2023) |
| Glofitamab | CD20, CD3e; IgG1λ/ҡ bispecific | Diffuse large B-cell lymphoma | In review | NA |
| Penpulimab | PD-1; Humanized IgG1ҡ | Metastatic nasopharyngeal carcinoma | NA | In review |
| Inolimomab | CD25; Murine IgG1ҡ | Acute graft-vs-host disease | NA | In review |
| Donanemab | Amyloid β; Humanized IgG1ҡ | Early Alzheimer’s disease | NA | In review (Q1 2023) |
| Lebrikizumab | IL-13; Humanized IgG4κ | Atopic dermatitis | In review | NA |
| Epcoritamab | CD20, CD3; Humanized IgG1κ/λ bispecific | Large B-cell lymphoma | In review | In review (PDUFA date 5/21/2023) |
| Tislelizumab | PD-1; Humanized IgG4ҡ | Esophageal squamous cell carcinoma | In review | In review (2nd cycle) |
| Retifanlimab | PD-1; Humanized IgG4ҡ | Carcinoma of the anal canal | Application withdrawn | In review (2nd cycle) |
| Narsoplimab | MASP-2; Human IgG4λ | Hematopoietic stem cell transplant-associated thrombotic microangiopathy | NA | In review (CRL appealed) |
| Sintilimab | PD-1; Human IgG4ҡ | Non-small cell lung cancer | NA | In review (2nd cycle) |
| 131I-Omburtamab | B7-H3; Murine IgG1κ; radiolabeled | CNS/leptomeningeal metastasis from neuroblastoma | In review | In review |