BLAINJECTIONINJECTABLEPriority Review
Approved
Jan 2022
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
4/8 — Partial
Priority Review
KIMMTRAK (tebentafusp) by Immunocore is glycoprotein 100 peptide-human leukocyte antigen-directed antibody interactions [moa]. First approved in 2022.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KIMMTRAK (tebentafusp) is a bispecific antibody that engages T cells to recognize and kill melanoma cells expressing gp100 and HLA. It represents a novel immunotherapy mechanism—a T cell engager—distinct from checkpoint inhibitors and traditional monoclonal antibodies. The drug is administered intravenously and designed for patients with unresectable or metastatic uveal melanoma.
Peak
Early-peak product with moderate competitive pressure (30%); small patient population suggests focused, specialized commercial team focused on oncology specialists.
Mechanism of Action
Glycoprotein 100 Peptide-Human Leukocyte Antigen-directed Antibody Interactions
Pharmacologic Class:
Bispecific gp100 Peptide-HLA-directed CD3 T Cell Engager
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma
Started Dec 2025
18 enrolled
Metastatic Uveal Melanoma
A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma
Started Oct 2025
47 enrolled
HLA-A*0201 Positive Cells PresentClear Cell Sarcoma (CCS)
Neoadjuvant Tebentafusp for Uveal Melanoma
Started Sep 2025
19 enrolled
Locally Advanced Unresectable Uveal Melanoma
Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma
Started Aug 2025
44 enrolled
Uveal Melanoma
Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
Started Feb 2025
30 enrolled
Metastatic Uveal MelanomaMetastatic Uveal Melanoma in the Liver
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.