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 | 2025-12-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| esophageal squamous cell carcinoma | — | D000077277 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
702 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 3 | 2 | 1 | — | — | 5 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 3 | 2 | 1 | — | — | 5 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | 2 | 2 | — | — | 4 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 3 | 1 | 1 | — | — | 4 |
| Colorectal neoplasms | D015179 | — | — | — | 3 | 1 | — | — | 4 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | 2 | — | — | 3 |
| Microsatellite instability | D053842 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 10 | 7 | — | — | — | 12 |
| Lymphoma | D008223 | — | C85.9 | 2 | 3 | — | — | — | 4 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | 4 | — | — | — | 4 |
| Esophageal squamous cell carcinoma | D000077277 | — | — | — | 2 | — | — | — | 2 |
| Non-muscle invasive bladder neoplasms | D000093284 | — | — | — | 2 | — | — | — | 2 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | 1 | — | — | — | 1 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 1 | 1 | — | — | — | 1 |
| Follicular lymphoma | D008224 | — | C82 | 1 | 1 | — | — | — | 1 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | 1 | 1 | — | — | — | 1 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 1 | 1 | — | — | — | 1 |
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Indications Without Phase
No data
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
Revenue by drug
$
€
£
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Tislelizumab – BeOne Medicines
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,411 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,106 adverse events reported
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