Tislelizumab - PharmaKB

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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Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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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

Reference product - 351(a)

Interchangeable product - 351(k)

Biosimilar product - 351(k)

Tislelizumab

Tradename	Proper name	Company	Number	Date	Products
Tevimbra	tislelizumab-jsgr	Beigene	N-761232 RX	2024-03-13	1 products

Labels

FDA

EMA

Brand Name	Status	Last Update
tevimbra	Biologic Licensing Application	2026-09-01

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
esophageal squamous cell carcinoma	—	D000077277	—

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

L: Antineoplastic and immunomodulating agents

— L01: Antineoplastic agents

— L01F: Monoclonal antibodies and antibody drug conjugates

— L01FF: Pd-1/pdl-1 (programmed cell death protein 1/death ligand 1) inhibitors

— L01FF09: Tislelizumab

HCPCS

No data

Clinical

Clinical Trials

847 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-small-cell lung carcinoma	D002289	—	—	22	64	32	4	7	117
Carcinoma	D002277	—	C80.0	14	62	6	1	25	103
Hepatocellular carcinoma	D006528	—	C22.0	11	52	5	1	32	95
Liver neoplasms	D008113	EFO_1001513	C22.0	8	34	3	1	24	64
Esophageal squamous cell carcinoma	D000077277	—	—	5	37	7	1	5	50
Lung neoplasms	D008175	—	C34.90	7	33	7	1	6	49
Lymphoma	D008223	—	C85.9	10	20	1	1	1	27
Small cell lung carcinoma	D055752	—	—	2	15	3	3	4	25
Neoadjuvant therapy	D020360	—	—	4	15	2	1	1	22
Urinary bladder neoplasms	D001749	—	C67	5	13	2	1	—	18

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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	58	44	4	—	5	84
Colorectal neoplasms	D015179	—	—	17	47	3	—	5	61
Stomach neoplasms	D013274	EFO_0003897	C16	16	42	7	—	5	58
Squamous cell carcinoma of head and neck	D000077195	—	—	8	25	2	—	—	33
Immunotherapy	D007167	—	—	5	24	1	—	4	30
Rectal neoplasms	D012004	—	—	2	22	5	—	2	29
Nasopharyngeal carcinoma	D000077274	—	—	1	18	6	—	2	27
Neoplasm metastasis	D009362	EFO_0009708	—	9	15	5	—	2	26
Esophageal neoplasms	D004938	—	C15	2	22	2	—	2	26
Squamous cell carcinoma	D002294	—	—	1	20	1	—	4	26

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Triple negative breast neoplasms	D064726	—	—	4	13	—	—	1	15
Biliary tract neoplasms	D001661	—	C24.9	1	14	—	—	1	15
Head and neck neoplasms	D006258	—	—	3	10	—	—	—	12
Melanoma	D008545	—	—	5	8	—	—	—	11
Uterine cervical neoplasms	D002583	—	—	1	9	—	—	1	11
T-cell lymphoma	D016399	—	—	5	9	—	—	1	10
T-cell lymphoma peripheral	D016411	—	—	4	7	—	—	1	8
Renal cell carcinoma	D002292	EFO_0000376	—	4	5	—	—	—	7
Ovarian neoplasms	D010051	EFO_0003893	C56	2	3	—	—	1	6
Extranodal nk-t-cell lymphoma	D054391	—	C86.0	2	6	—	—	—	6

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Skin neoplasms	D012878	EFO_0004198	C44	1	—	—	—	—	1
Adenoid cystic carcinoma	D003528	—	—	1	—	—	—	—	1
Hereditary nonpolyposis colorectal neoplasms	D003123	EFO_0007354	—	1	—	—	—	—	1
Acinar cell carcinoma	D018267	—	—	1	—	—	—	—	1
Ascites	D001201	—	R18	1	—	—	—	—	1
Gastrointestinal neoplasms	D005770	—	C26.9	1	—	—	—	—	1
Malignant pleural effusion	D016066	—	J91.0	1	—	—	—	—	1
Pseudomyxoma peritonei	D011553	EFO_0007456	—	1	—	—	—	—	1
Lymphatic metastasis	D008207	EFO_1001364	—	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
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