Tislelizumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2023
- First approval year
- 2023
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Tislelizumab
- tevimbra
- Tevimbra
- tizveni
- Tizveni
- bgb a317
- Bgb-a317
- BGB-A317
- bgba 317
- BGBA-317
- bgba317
- BGBA317
- bgn 1
- BGN-1
- bgn1
- BGN1
- Intravenous Tislelizumab
- jhl 2108
- JHL-2108
- jhl2108
- JHL2108
- Subcutaneous Tislelizumab
- tevimbra
- Tevimbra
- Tisleizumab(BGB-A317)
- tislelizumab
- Tislelizumab
- Tislelizumab (BGB-A317)
- Tislelizumab (i.v. 200mg)
- tislelizumab [INN]
And 17 more, listed on the interactive page.
- ATC classification codes
- L01FF09
Sources for recorded values
- CAS registry numbers
- 1858168-59-8
- ChEMBL ID
- CHEMBL4297840
- FDA ingredient codes (UNII)
- 0KVO411B3N
- 2677425
- 2677426
- Applicant
- BEIGENE
- Approval date
- 13 Mar 2024
- Application number
- BLA761232
- Status
- Authorised
- Status date
- 15 Sept 2023
- Authorisation date
- 15 Sept 2023
- Approved indications
- Non-small cell lung cancer (NSCLC) Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable NSCLC at high risk of recurrence (for selection criteria, see section 5.1).Tevimbra in combination with pemetrexed and platinum containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have: locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC. Tevimbra in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous NSCLC who have: locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC. Tevimbra as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab. Small Cell Lung Cancer (SCLC)Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC. Gastric or gastroesophageal junction (G/GEJ) adenocarcinomaTevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD L1 with a tumour area positivity (TAP) score ≥ 5% (see section 5.1).Oesophageal squamous cell carcinoma (OSCC)Tevimbra, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD L1 with a TAP score ≥ 5% (see section 5.1).Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic OSCC after prior platinum-based chemotherapy. Nasopharyngeal carcinoma (NPC)Tevimbra, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic NPC.
- Product number
- EMEA/H/C/005919
- Authorisation holder
- Beone Medicines Ireland Limited
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Carcinoma, Non-Small-Cell Lung
- Esophageal Squamous Cell Carcinoma
- Nasopharyngeal Carcinoma
- Small Cell Lung Carcinoma
- Stomach Neoplasms
European medicines record
- Patents
- 0
- Designations
- 2
- Earliest recorded loss of exclusivity
- 3 Mar 2032
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- tislelizumab
- Type
- Antibody
- Drug name stem
- -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
- Action
- Binding
- Action type
- Binding
- Target
- programmed cell death 1 (CD279)
- Gene symbol
- PDCD1
- Protein identifier
- Q15116
- Median affinity
- 9.82
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Programmed cell death protein 1 inhibitor
- Action type
- Inhibitor
- Target
- Programmed cell death protein 1
- Protein identifier
- Q15116
Open Targets mechanisms
- Mechanism
- Programmed cell death protein 1 inhibitor
- Action type
- Inhibitor
- Target
- Programmed cell death protein 1
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Hodgkin Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000196
- Subject identifier
- D011471
- Condition
- Squamous Cell Carcinoma of Head and Neck
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000199
- Subject identifier
- D000077195
- Condition
- Lymphoma, T-Cell, Peripheral
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000211
- Subject identifier
- D016411
- Condition
- Adenocarcinoma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000228
- Subject identifier
- D000230
- Condition
- Astrocytoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000272
- Subject identifier
- D001254
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000294
- Subject identifier
- D001749
- Condition
- Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000313
- Subject identifier
- D002277
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000349
- Subject identifier
- D002292
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000365
- Subject identifier
- D015179
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000503
- Subject identifier
- D013274
- Condition
- Glioblastoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Leukemia
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Adenocarcinoma of Lung
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000571
- Subject identifier
- D000077192
- Condition
- Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Oligodendroglioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000632
- Subject identifier
- D009837
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000707
- Subject identifier
- D002294
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000708
- Subject identifier
- D002294
- Condition
- Melanoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
And 45 more, listed on the interactive page.
- Condition identifier
- EFO_0000181
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000183
- Condition identifier
- EFO_0000228
- Condition identifier
- EFO_0000272
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000294
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000313
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000403
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000503
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000519
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000571
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000632
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000702
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000707
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000708
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Condition identifier
- EFO_0003860
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003891
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003897
- Condition identifier
- EFO_0004252
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005537
- Highest recorded phase
- 2
And 130 more, listed on the interactive page.
- Event
- abdominal infection
- Reports
- 3
- Reporting signal score
- 11.1503
- Event
- abdominal pain
- Reports
- 17
- Reporting signal score
- 15.5309
- Event
- adrenal insufficiency
- Reports
- 6
- Reporting signal score
- 15.325
- Event
- alanine aminotransferase increased
- Reports
- 25
- Reporting signal score
- 52.7616
- Event
- anaemia
- Reports
- 41
- Reporting signal score
- 70.9029
- Event
- ascites
- Reports
- 5
- Reporting signal score
- 7.84867
- Event
- aspartate aminotransferase increased
- Reports
- 25
- Reporting signal score
- 55.587
- Event
- bile acids increased
- Reports
- 1
- Reporting signal score
- 6.67785
- Event
- blood alkaline phosphatase increased
- Reports
- 5
- Reporting signal score
- 7.17089
- Event
- blood bilirubin increased
- Reports
- 11
- Reporting signal score
- 24.0246
- Event
- blood creatinine increased
- Reports
- 7
- Reporting signal score
- 7.46466
- Event
- cardiotoxicity
- Reports
- 3
- Reporting signal score
- 6.37073
- Event
- cerebral radiation injury
- Reports
- 1
- Reporting signal score
- 7.68915
- Event
- constipation
- Reports
- 12
- Reporting signal score
- 10.5499
- Event
- cytokine increased
- Reports
- 1
- Reporting signal score
- 9.07532
- Event
- cytokine release syndrome
- Reports
- 3
- Reporting signal score
- 6.1926
- Event
- cytopenia
- Reports
- 4
- Reporting signal score
- 8.91039
- Event
- decreased appetite
- Reports
- 32
- Reporting signal score
- 58.1168
- Event
- dermatitis
- Reports
- 5
- Reporting signal score
- 10.905
- Event
- diarrhoea
- Reports
- 43
- Reporting signal score
- 43.0863
- Event
- drug-induced liver injury
- Reports
- 5
- Reporting signal score
- 7.17167
- Event
- endocrine toxicity
- Reports
- 1
- Reporting signal score
- 6.30336
- Event
- fatigue
- Reports
- 32
- Reporting signal score
- 21.9411
- Event
- gastrointestinal disorder
- Reports
- 7
- Reporting signal score
- 8.98437
- Event
- gastrointestinal haemorrhage
- Reports
- 8
- Reporting signal score
- 8.21261
And 48 more, listed on the interactive page.
- NCT02407990
- NCT04164199
- NCT04170283
- NCT04985721
- NCT05516914
- NCT02660034
- NCT03379259
- NCT03666143
- NCT03736889
- NCT04047862
- NCT04068519
- NCT04577963
- NCT04649385
- NCT04716634
- NCT05014828
- NCT05494762
- NCT05505877
- NCT05508100
- NCT05605496
- NCT05644626
- NCT05758389
- NCT05798533
- NCT05809336
- NCT05840835
- NCT05904496
And 267 more, listed on the interactive page.
- Dose
- 150 mg or 200 mg or 300 mg or 400 mg
- Route
- Intravenous
- How often
- Every 2 weeks or every 3 weeks or every 4 weeks or every 6 weeks
- Administer by intravenous infusion
- Do not coadminister other drugs through same line
- Do not inject as a bolus
- Initial infusion duration varies by dose: 150 mg over 60 min, 200 mg over 60 min, 300 mg over 90 min, 400 mg over 120 min
- Subsequent infusions can be shorter (30-60 min) if tolerated
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QVQLQESGPGLVKPSETLSLTCTVSGFSLTSYGVHWIRQPPGKGLEWIGVIYADGSTNYNPSLKSRVTISKDTSKNQVSLKLSSVTAADTAVYYCARAYGNYWYIDVWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPPVAGGPSVFLFPPKPKDTLMISRTPEVTCVVVAVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVVHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- Component
- Light chain
- Type
- Protein
- Sequence
- DIVMTQSPDSLAVSLGERATINCKSSESVSNDVAWYQQKPGQPPKLLINYAFHRFTGVPDRFSGSGYGTDFTLTISSLQAEDVAVYYCHQAYSSPYTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Glycosylation sites (N)
- Sequence
- Asn295 $ Asn295''''
- Component
- Disulfide bridges
- Sequence
- 22-95 $ 22''-95'' $ 23-88' $ 23'''-88''' $ 132-214' $ 132''-214''' $ 134'-194' $ 134'''-194''' $ 145-201 $ 145''-201'' $ 224-224'' $ 227-227'' $ 259-319 $ 259''-319'' $ 365-423 $ 365''-423''
- Component
- Glycosylation sites (N)
- Sequence
- Asn295 $ Asn295''
- 72579-121
- 72579-125
Related records
Trials (603)
- - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases
- "Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer"
- A Clinical Study on Neoadjuvant Treatment of Resectable Head and Neck Squamous Carcinoma With Immune-targeted Therapy and Lysogenic HSV Virus
- A Clinical Study to Explore the Efficacy and Safety of Tislelizumab in Combination With Bevacizumab and Chemotherapy in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer
- A Clinical Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma.
- A Clinical Trial Comparing Low-Dose RT + Targeted Therapy+ Immunotherapy vs Targeted Therapy+ Immunotherapy Alone as Neoadjuvant Therapy in Operable HNSCC Patients.
- A Clinical Trial of Firsekibart, Tislelizumab, and Lenvatinib in Patients With Unresectable, TP53-Mutated Hepatocellular Carcinoma
- A Clinical Trial of Neoadjuvant Targeted Therapy, Immunotherapy, and Lysogenic HSV-Based Virotherapy in Resectable Head and Neck Squamous Cell Carcinoma
- A Dose Escalation and Dose Expansion Clinical Study of STI-7349 in Subjects With Advanced Solid Tumors
- A First-in-Human Study Investigating BG-85738 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors With Rat Sarcoma Virus (RAS) Mutations
- A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors
- A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification
- A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
- A Multi-center, Non-randomized, Open-label Phase II Clinical Study on the Treatment of Newly Diagnosed Advanced Hodgkin's Lymphoma With PD-1 Antibody (Tislelizumab) Combined With AVD Regimen (Doxorubicin, Vindesine, Dacarbazine) Under the Guidance of PET/CT
- A Multicenter Phase II Trial of Post-operative Concurrent Chemoradiotherapy Using Weekly Cisplatin With Tislelizumab for Patients With High-risk Head and Neck Squamous Cell Carcinoma：The POTENTIAL Study
- A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for r/r FL
- A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer
- A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors
- A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy
- A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Participants With Advanced Solid Tumors
Approved for (10)
- Adenocarcinoma
- Cancer
- Esophageal cancer
- Esophageal squamous cell carcinoma
- Gastric adenocarcinoma
- Gastric cancer
- Gastric neoplasm
- Gastroesophageal junction adenocarcinoma
- Neoplasm
- Non-small cell lung carcinoma
In development for (60)
- Astrocytoma (excluding glioblastoma) Phase 2
- Biliary tract cancer Phase 2
- Biliary tract neoplasm Phase 2
- Breast cancer Phase 3
- Carcinoma Phase 2
- Cervical adenocarcinoma Phase 2
- Cervical cancer Phase 2
- Cervical squamous cell carcinoma Phase 1
- Cholangiocarcinoma Phase 3
- Classic Hodgkin lymphoma Phase 3
- Clear cell renal carcinoma Phase 2
- Colonic neoplasm Phase 2
- Colorectal adenocarcinoma Phase 2
- Colorectal cancer Phase 2
- Colorectal carcinoma Phase 2
- Colorectal neoplasm Phase 2
- Diffuse large B-cell lymphoma Phase 3
- Digestive system neoplasm Phase 1
- Endometrial cancer Phase 1
- Exocrine pancreatic carcinoma Phase 2
Targets (1)
- PDCD1 Programmed cell death protein 1 inhibitor