Tebentafusp
The first drug to improve survival in metastatic uveal melanoma, and the first TCR-based bispecific.
Approved 2022 for HLA-A*02:01-positive metastatic uveal melanoma (OS 21.7 vs 16.0 months). Also being tested in cutaneous melanoma after PD-1 (TEBE-AM). Immunocore's PRAME-directed brenetafusp follows.
No public structure of tebentafusp; intact IgG shown as reference.
1.Soluble high-affinity TCR binds gp100 peptide presented on HLA-A*02:01 on melanoma cells
- Route
- IV infusion
- Schedule
- 20 µg day 1, 30 µg day 8, 68 µg day 15, then 68 µg weekly
- Dose modifications
- Hold for grade ≥3 CRS; skin reactions managed with antihistamines and steroids
- Monitoring
- Inpatient monitoring for first three doses; blood pressure, temperature, LFTs
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. 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. Weekly infusion for HLA-A*02:01-positive uveal melanoma; first doses in hospital for CRS monitoring.
- 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. HLA-A*02:01 genotype must be documented.
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.
- Appraised for
- HLA-A*02:01-positive unresectable or metastatic uveal melanoma
- Notes
- NICE recommended tebentafusp in 2023 with a commercial arrangement. TA number not verified; follow the NICE search link.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE search: tebentafusp · SMC advice: tebentafusp. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- Feb 2021DesignationUS
Breakthrough Therapy designation source
- 25 Jan 2022ApprovalUS
HLA-A*02:01+ unresectable or metastatic uveal melanoma: first TCR therapeutic approved source
- Apr 2022ApprovalEU
EMA approval source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2022 | HLA-A*02:01+ metastatic uveal melanoma |
| Adverse event |
|---|
| Cytokine release syndrome |
| Rash |
| Pyrexia |
| Pruritus |
| Fatigue |
| Nausea |
| Hypotension |
| Transaminase increase |
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.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | kimmtrak.com |
| United Kingdom | NICE: recommended for HLA-A*02:01+ metastatic uveal melanoma (TA867) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Tebentafusp" OR ABSTRACT:"Tebentafusp" OR TITLE:"Kimmtrak" OR ABSTRACT:"Kimmtrak") 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 Tebentafusp, not a curated reading list.