Tevimbra(tislelizumab)
Tevimbra (tislelizumab) is an antibody pharmaceutical. Tislelizumab was first approved as Tevimbra on 2023-09-15. It is used to treat esophageal squamous cell carcinoma in the USA. It has been approved in Europe to treat esophageal squamous cell carcinoma. The pharmaceutical is active against programmed cell death protein 1.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| digestive system diseases | D004066 |
Trade Name
FDA
EMA
Tevimbra
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tevimbra | Biologic Licensing Application | 2025-01-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| esophageal squamous cell carcinoma | — | D000077277 | — |
Agency Specific
FDA
EMA
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Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
574 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 21 | 99 | 15 | 2 | 25 | 151 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 10 | 36 | 3 | 1 | 29 | 74 |
| Non-small-cell lung carcinoma | D002289 | — | — | 15 | 36 | 19 | 2 | 3 | 70 |
| Lung neoplasms | D008175 | — | C34.90 | 9 | 34 | 17 | 1 | 4 | 60 |
| Squamous cell carcinoma | D002294 | — | — | 8 | 39 | 7 | 1 | 1 | 52 |
| Lymphoma | D008223 | — | C85.9 | 11 | 27 | 3 | 1 | 1 | 35 |
| Esophageal squamous cell carcinoma | D000077277 | — | — | 4 | 24 | 5 | 1 | 1 | 32 |
| Urinary bladder neoplasms | D001749 | — | C67 | 3 | 15 | 2 | 1 | — | 18 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 12 | 1 | 1 | 1 | 15 |
| Neoadjuvant therapy | D020360 | — | — | 2 | 10 | 2 | 1 | — | 14 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 45 | 37 | 5 | — | 3 | 67 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 8 | 32 | 4 | — | 22 | 60 |
| Colorectal neoplasms | D015179 | — | — | 11 | 40 | 3 | — | 5 | 51 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 12 | 35 | 5 | — | 3 | 45 |
| Adenocarcinoma | D000230 | — | — | 2 | 17 | 4 | — | 4 | 26 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 5 | 20 | 2 | — | — | 26 |
| Rectal neoplasms | D012004 | — | — | — | 21 | 4 | — | 2 | 25 |
| Immunotherapy | D007167 | — | — | 3 | 19 | 2 | — | 3 | 24 |
| Esophageal neoplasms | D004938 | — | C15 | 2 | 20 | 2 | — | — | 22 |
| Recurrence | D012008 | — | — | 2 | 16 | 3 | — | 1 | 21 |
Show 23 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | — | — | 5 | 8 | — | — | — | 11 |
| Triple negative breast neoplasms | D064726 | — | — | 2 | 10 | — | — | 1 | 11 |
| Uterine cervical neoplasms | D002583 | — | — | 1 | 9 | — | — | 1 | 11 |
| Head and neck neoplasms | D006258 | — | — | 4 | 9 | — | — | — | 11 |
| T-cell lymphoma | D016399 | — | — | 3 | 9 | — | — | 1 | 10 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 1 | 10 | — | — | — | 10 |
| T-cell lymphoma peripheral | D016411 | — | — | 3 | 8 | — | — | 1 | 9 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 4 | 5 | — | — | — | 7 |
| Squamous cell neoplasms | D018307 | — | — | 1 | 5 | — | — | — | 5 |
| Thrombosis | D013927 | — | — | — | 3 | — | — | 2 | 5 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Molecular targeted therapy | D058990 | — | — | 1 | — | — | — | 1 | 2 |
| Adenoid cystic carcinoma | D003528 | — | — | 1 | — | — | — | — | 1 |
| Hereditary nonpolyposis colorectal neoplasms | D003123 | EFO_0007354 | — | 1 | — | — | — | — | 1 |
| Acinar cell carcinoma | D018267 | — | — | 1 | — | — | — | — | 1 |
| Mullerian mixed tumor | D018200 | — | — | 1 | — | — | — | — | 1 |
| Ascites | D001201 | — | R18 | 1 | — | — | — | — | 1 |
| Germ cell and embryonal neoplasms | D009373 | — | — | 1 | — | — | — | — | 1 |
| Endodermal sinus tumor | D018240 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Catheter ablation | D017115 | — | — | — | — | — | — | 2 | 2 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | — | 1 | 1 |
| Venous thrombosis | D020246 | — | I82.40 | — | — | — | — | 1 | 1 |
| Acute kidney injury | D058186 | — | N17 | — | — | — | — | 1 | 1 |
| Radiosurgery | D016634 | — | — | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | — | — | — | 1 | 1 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | — | 1 | 1 |
| Sensitivity and specificity | D012680 | — | — | — | — | — | — | 1 | 1 |
| Glandular and epithelial neoplasms | D009375 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tislelizumab |
| INN | tislelizumab |
| Description | Tislelizumab, sold under the brand name Tevimbra among others, is a humanized monoclonal antibody directed against PD-1. It prevents PD-1 from binding to the ligands PD-L1 and PD-L2 (hence it is a checkpoint inhibitor). It is designed to bind less to Fc gamma receptors. It is being developed by BeiGene (after a period with Celgene Corp).
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >7CGW:A,H|Heavy chain of tislelizumab Fab
QVQLQESGPGLVKPSETLSLTCTVSGFSLTSYGVHWIRQPPGKGLEWIGVIYADGSTNYNPSLKSRVTISKDTSKNQVSL
KLSSVTAADTAVYYCARAYGNYWYIDVWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWN
SGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPHHHHHH
>7CGW:B,L|Light chain of tislelizumab Fab
DIVMTQSPDSLAVSLGERATINCKSSESVSNDVAWYQQKPGQPPKLLINYAFHRFTGVPDRFSGSGYGTDFTLTISSLQA
EDVAVYYCHQAYSSPYTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ
ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Identifiers
| PDB | 7BXA, 7CGW |
| CAS-ID | 1858168-59-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297840 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14922 |
| UNII ID | 0KVO411B3N (ChemIDplus, GSRS) |
Target
Agency Approved
PDCD1
PDCD1
Alternate
No data
Variants
No data
Financial
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Tislelizumab – Beigene
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,973 adverse events reported
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