Drug · Monoclonal Antibody
Tislelizumab
CI-DRUG-00000594Explore in graph →NCIt C152661 CHEMBL4297840 CIViC Approved
Regulatory
Approvals (17)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- Health Canada — Drug Product Database (DPD)
- Dataset
- Health Canada DPD
- Version
- dpd-2026-09-11
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- Open Government Licence – Canada (https://open.canada.ca/en/open-government-licence-canada)
- Run
- ING-HEALTHCANADADPD-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| CA Health Canada | — | Marketed in Canada as TEVIMBRA (DIN 02564009) under ATC L01FF09 TISLELIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Apr 1, 2026 | health-canada-dpd |
| EU EMA | — | Non-small cell lung cancer (NSCLC)Tizveni in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous non-small cell lung cancer 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.Tizveni in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous non-small cell lung cancer who have:• locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or• metastatic NSCLC.Tizveni as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab. | withdrawn | Apr 19, 2024 | ema |
| EU |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 18 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 210 | 107 | 58 | 396 | 17 | CA, EU, US | Sep 15, 2023 | Jun 2, 2015 |
| Malignant Esophageal Neoplasm | Approved | Phase 3 | 20 | 12 | 8 | 34 | 3 | US | Mar 13, 2024 | Jul 18, 2017 |
| Malignant Lung Neoplasm | Phase4 | Phase 4 | 46 | 20 | 25 | 78 | 0 | — | — | Nov 30, 2017 |
| Hodgkin Lymphoma | Phase4 | Phase 4 | 5 | 3 | 3 | 10 | 0 |
Curated evidence
Clinical evidence (1)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 42558558
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| EGFR S768_D770dup1 | ||||||||
| Paclitaxel + Tislelizumab | ||||||||
Clinical trials
Trials with this intervention (407)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT05981703 | A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors | recruiting | Phase 1 | 337 | BeOne MedicinesINDUSTRY | 4 | Sep 28, 2026 | clinicaltrials |
| NCT07414836 | A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors | recruiting | Phase 1 |