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
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2026-08-25 (see label) | approved | Aug 25, 2026 | openfda |
| US FDA | — | Efficacy supplement 2025-12-09 (see label) | approved | Dec 9, 2025 | openfda |
| US FDA | — | Efficacy supplement 2025-12-09 (see label) | approved | Dec 9, 2025 | openfda |
| US FDA | — | Efficacy supplement 2025-12-09 (see label) | approved | Dec 9, 2025 | openfda |
| US |
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 | 212 | 107 | 58 | 398 | 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 | 47 | 20 | 25 | 79 | 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 (409)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT04985721 | A Trial of Pamiparib With Tislelizumab in Patients With Advanced Tumours With Homologous Recombination Repair Defects(IMPARP-HRD) | unknown | Phase 2 | 60 | Peter MacCallum Cancer Centre, AustraliaOTHER | 1 | Mar 15, 2023 | clinicaltrials |
| NCT05536102 | The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy) |