Tislelizumab
A Chinese-developed PD-1 blocker, engineered to avoid a side-channel that may blunt other PD-1 drugs, now approved in the US and EU for oesophageal and stomach cancer.
Humanised IgG4 with an Fc engineered to minimise FcγR binding (reducing macrophage-mediated T-cell clearance). US approvals: second-line ESCC (March 2024), first-line HER2-negative gastric/GEJ with chemotherapy (December 2024, RATIONALE-305), first-line ESCC PD-L1 ≥1% with chemotherapy (March 2025, RATIONALE-306). Also the PD-1 partner in HERIZON-GEA-01 with zanidatamab. Approved in China across many indications since 2019.
1.Tislelizumab binds PD-1 on exhausted T cells
- Route
- Intravenous
- Schedule
- 200 mg every 3 weeks
- Dose modifications
- Withhold or discontinue for immune-related adverse events per label
- Monitoring
- Thyroid, liver, glucose; immune-related toxicity
Source: www.drugs.com/history/tevimbra.html. Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. FDA-approved (oesophageal and gastric cancers); newer entrant with lower US uptake.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
- Assistance programmes
- myBeiGene
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Notes
- MHRA-licensed 2024 for oesophageal squamous cell carcinoma; NICE appraisals for ESCC and NSCLC were in progress or recently published. Check NICE.
Sources: NICE search: tislelizumab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- Mar 2024ApprovalUS
Second-line ESCC (RATIONALE-302)
- Dec 2024ApprovalUS
First-line gastric/GEJ (RATIONALE-305)
- 4 Mar 2025ApprovalUS
First-line ESCC PD-L1 ≥1% (RATIONALE-306)
Approvals
| Region | Year | Indication |
|---|---|---|
| China | 2019 | Classical Hodgkin lymphoma (first); subsequently urothelial, NSCLC, HCC, ESCC, gastric, nasopharyngeal |
| US | 2024 | Second-line ESCC after chemotherapy; first-line HER2-negative gastric/GEJ with chemotherapy (PD-L1 ≥1) |
| US | 2025 | First-line ESCC, PD-L1 ≥1%, with platinum chemotherapy |
| Adverse event |
|---|
| Immune-related adverse events (thyroiditis, pneumonitis, colitis, hepatitis) |
| Rash, fatigue |
Class effects of PD-1 blockade. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Tislelizumab" OR ABSTRACT:"Tislelizumab" OR TITLE:"Tevimbra" OR ABSTRACT:"Tevimbra" OR TITLE:"BGB-A317" OR ABSTRACT:"BGB-A317") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Tislelizumab, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductCamrelizumab
Shares CSCO guidelines (China), Nasopharyngeal carcinoma, Immune-related adverse events (irAEs), Regulatory divergence between regions.
- ProductToripalimab
Shares CSCO guidelines (China), Nasopharyngeal carcinoma, Immune-related adverse events (irAEs), Regulatory divergence between regions.
- ProductZanidatamab
Shares HERIZON-GEA-01, Biomarker-directed first-line quadruplets in gastric cancer, BeOne Medicines (formerly BeiGene), Oesophageal cancer.
- ProductPenpulimab
Shares CSCO guidelines (China), Nasopharyngeal carcinoma, PD-1, Immune checkpoint inhibitors.
- CompanyJiangsu Hengrui Pharmaceuticals
Shares Nasopharyngeal carcinoma, Oesophageal cancer, Hepatocellular carcinoma, Non-small-cell lung cancer.
- InstitutionChinese Society of Clinical Oncology
Shares CSCO guidelines (China), Oesophageal cancer, Hepatocellular carcinoma, Gastric & gastro-oesophageal junction cancer.
- InstitutionHenan Cancer Hospital
Shares Oesophageal cancer, Gastric & gastro-oesophageal junction cancer, Immune checkpoint inhibitors, Non-small-cell lung cancer.
- TrialCheckMate 649
Shares Biomarker-directed first-line quadruplets in gastric cancer, Oesophageal cancer, PD-1, Gastric & gastro-oesophageal junction cancer.