Tebentafusp 100micrograms/0.5ml solution for infusion vials
Requires a prescription from a doctor or prescriber
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Safety monitoring data
Yellow Card reports
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Suspected adverse reactions reported for Tebentafusp
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
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Suspected adverse reactions reported for Tebentafusp
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1 branded products available
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Kimmtrak 100micrograms/0.5ml concentrate for solution for infusion vials
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
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Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
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Codes for healthcare professionals and prescribing systems
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 24 · Randomised trials: 6 · 2019–2026
Showing the 50 most relevant studies, sorted by most relevant.
Anne Petzold, Theresa Steeb, Anja Wessely, et al.
Cancer Treatment Reviews, 2023
- Antineoplastic Agents
- Systematic Reviews as Topic
- Immune Checkpoint Inhibitors
Muhammed Shabil, Ganesh Bushi, Nishant Rai, et al.
Human Vaccines & Immunotherapeutics, 2024
Dear editorWe have reviewed the systematic review and meta-analysis conducted by Dian et al.1 which assessed the efficacy and safety of tebentafusp in patients with metastatic uveal melanoma. The r...
Abstract licence: CC BY-NC 4.0
Yating Dian, Yihuang Liu, Furong Zeng, et al.
Human Vaccines & Immunotherapeutics, 2024
- Melanoma
- Uveal Neoplasms
- Uveal Melanoma
Patients with metastatic uveal melanoma (mUM) have a poor prognosis, and few appropriate medications are available. Tebentafusp is approved by the Food and Drug Administration for mUM recently. However, the real efficacy and safety of tebentafusp are still unclear. We searched PubMed, Embase, and Cochrane Library from inception to March 20, 2024. The research was reported based on the preferred reporting items for systematic reviews and meta-analysis guidelines. We used random effects models to aggregate data on the response rates and adverse events of tebentafusp therapy. Six studies met the inclusion criteria with a total sample of 589 participants. The pooled objective response rate was 0.08 (95% CI: 0.05-0.12), and pooled disease control rate was 0.51 (95% CI: 0.44-0.57). The overall incidence was 0.99 (95% CI: 0.95-1.00) for any grade adverse events, 0.50 (95% CI: 0.41-0.59) for grade 3-4 adverse events, and 0.01 (95% CI: 0-0.03) for discontinuation due to adverse events. Tebentafusp exhibits promising treatment outcomes for mUM patients. Although accompanied with a common occurrence of adverse events, which can typically be managed and controlled. Future research is necessary for substantiating these findings and refining guidelines for management of mUM.
Abstract licence: CC BY-NC 4.0
Yanlin Wang, Wen Sun, Bing Wang
Frontiers in Oncology, 2025
Noronha MM, da Silva LFL, Almeida LFC, et al.
2025
- Melanoma
- Uveal Neoplasms
- Circulating Tumor DNA
Metastatic uveal melanoma (mUM) is a rare disease associated with poor prognosis and limited therapeutic options. Recent studies showed that detecting ctDNA is feasible and can aid treatment decisions for patients with mUM. We systematically searched PubMed, EMBASE, and Cochrane databases for eligible studies published up to May 2025 that included patients with mUM and reported data on the association between ctDNA and survival outcomes (OS and PFS). Statistical analyses were performed using Review Manager 5.4 software. Of the initial 450 records, seven studies met eligibility, including 518 patients with mUM. At baseline, ctDNA positivity was associated with significantly worse PFS (HR 2.34; 95% CI 1.56-3.51; p 2 = 0%) and OS (HR 3.32; 95% CI 2.09-5.29; p 2 = 48%). In patients treated with tebentafusp, ctDNA clearance was associated with superior OS (HR 0.19; 95% CI 0.07-0.49; p 2 = 46%) and any decrease in ctDNA was associated with better OS (HR 0.42; 95% CI 0.22-0.80; p 2 = 0%). This meta-analysis underscores ctDNA as a potential predictor of worse survival in patients with mUM, highlighting its potential to refine risk stratification and guide treatment strategies. Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO): CRD42025638076.
Abstract licence: CC BY-NC-ND
P. Rutkowski, M. Dudzisz-Śledź, V. Urbonas, et al.
Oncology in Clinical Practice, 2024
Jessica C. Hassel, Sophie Piperno-Neumann, Piotr Rutkowski, et al.
New England Journal of Medicine, 2023
- Antineoplastic Combined Chemotherapy Protocols
- Melanoma
- Uveal Melanoma
Danyao Chen, Yuming Sun, Yating Dian, et al.
Human Vaccines & Immunotherapeutics, 2024
Han Cai, Zhilong Huang, Bing-Long Wang, et al.
Frontiers in Medicine, 2026
Jean Henri Maselli-Schoueri, Samuel David Saibil
Frontiers in Oncology, 2026
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
7.5 hours
Mechanism
Glycoprotein 100 (gp100) is a transmembrane glycoprotein highly expressed in mel…
Food interactions
None known
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
20 to 68 mg
Half-life
7.5 hours
[L39985]
Protein binding
Volume of distribution
7.56 L
[L39985]
Metabolism
[L39985]
Elimination
Clearance
16.4 L
[L39985]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Uveal melanoma is a rare ocular tumour with often poor prognosis and limited treatment options. Even after surgical ablation or removal of the ocular tumour, almost 50% of patients with uveal melanoma develop metastatic disease.[A244815] On January 26, 2022, tebentafusp was first approved by the FDA for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma. This approval marks the first bispecific T cell engager to be approved by the FDA to treat a solid tumour and being the first and only therapy for the treatment of unresectable or metastatic uveal melanoma to be approved by the FDA.[L39995] Tebentafusp was subsequently approved for the same indication in the EU in April 2022.[L41675]
[L39985]
Known interactions with other medicines. Always consult a healthcare professional.
Showing 38 of 38 interactions
Tebentafusp is a bispecific gp100 peptide-HLA-A*02:01 directed T cell receptor CD3 T cell engager. It consists of a TCR targeting domain - or a TCR arm - fused to a single-chain variable fragment (scFv) anti-CD3 effector domain.[A244815] The TCR arm binds to a gp100 peptide bound to HLA-A on the uveal melanoma tumour cell surface. The anti-CD3 effector domain of tebentafusp engages and activates CD3+ T cells to inflammatory cytokines and cytolytic proteins, which results in direct lysis of uveal melanoma tumour cells.[L39985] The anti-CD3 fragment of the drug has a lower affinity, so the T cells are not stimulated unless tebentafusp has detected gp100.[A244910]
Tebentafusp is only effective in HLA-A*02:01-positive patients.[L39985][A244910]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L39985]
[L39985]
[L39985]
[L39985]
[L39985]
Proteins and enzymes this drug interacts with in the body
May prevent pigmentation-associated toxicity by sequestering toxic reaction intermediates of eumelanin biosynthesis pathway
ATC L01XX75
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Tebentafusp
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72