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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.
Backbone ribbon from PDB 7CGW. RCSB PDB 7CGW. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
PD-1 blockade with reduced Fcγ receptor engagement. Connects to PD-1.
1.Tislelizumab binds PD-1 on exhausted T cells
Source: www.drugs.com/history/tevimbra.html. Doses are for orientation; the current label governs.
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.
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.
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.
Sources: NICE TA1068. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2021-01-11 | BeOne Medicines (formerly BeiGene) to Novartis Tislelizumab, anti-PD-1 antibody | Licence | $650m | up to $2.2bn | source |
Second-line ESCC (RATIONALE-302)
First-line gastric/GEJ (RATIONALE-305)
First-line ESCC PD-L1 ≥1% (RATIONALE-306)
FDA approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma source
| 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.
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Query 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.
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