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Drug

Tislelizumab

Approved · EMA
ClassProgrammed cell death protein 1 inhibitorEmerging researchLate-stage developmentRising momentum

Also known as Tevimbra, Tirilizumab, tirelizumab.

5
Research papers
107
Active clinical trials
Programmed cell death protein 1
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: Tevimbra (EMA)

Regulatory2023-09-15EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tislelizumab
Aliases & brands
TevimbraTirilizumabtirelizumab
RxNorm CUI
2677426
ChEMBL ID
CHEMBL4297840
ATC codes
L01FF09
UNII
0KVO411B3N
Primary mechanism
Programmed cell death protein 1 inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORProgrammed cell death protein 1 inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2023-09-15
Latest approval
2023-09-15
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2023-09-15Approval
Approval: Tevimbra (EMA)
Indication: Non-small cell lung cancer (NSCLC) Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment,Show full indication

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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

198 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
198
registered trials across all phases
LATEST COMPLETION 2026
107
Active studies
91
Recruiting
39
Late-stage (III+)
31
Completed
60
Discontinued
PHASE DISTRIBUTIONn = 198
Early Phase 13Phase 129Phase 1 / 219Phase 2108Phase 2 / 33Phase 329Phase 43Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20192024
Most influential
Recent papers
Major research themes8
Antineoplastic Combined Chemotherapy Protocols1Bevacizumab1Brain Neoplasms1Carcinoma, Non-Small-Cell Lung1Carcinoma, Squamous Cell1Circulating Tumor DNA1Glioblastoma1Immune Checkpoint Inhibitors1
Journals, researchers & institutions
Top journals
  • Cancer science1
  • JAMA oncology1
  • Journal of cancer research and clinical oncology1
  • Leukemia1
  • The Lancet. Oncology1
Leading researchers
  • Huang J2
  • Wu J2
  • Zhang J2
  • Zhou J2
  • Bao Y1
  • Bi F1
  • Bu C1
  • Bu X1
Leading institutions
free-text, unnormalised
  • Zhejiang Cancer Hospital3
  • Fudan University Shanghai Cancer Center2
  • Affiliated Cancer Hospital of Zhengzhou University1
  • Anhui Provincial Hospital1
  • Cancer Center1
  • Chinese Academy of Medical Sciences & Peking Union Medical College1

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 4 of the same disease areas as Tislelizumab in the shared literature.

4 shared diseases1 shared paper

Studied across 4 of the same disease areas as Tislelizumab in the shared literature.

4 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.