dotMD.com
Bispecific gp100 Peptide-HLA-directed CD3 T Cell Engager • Prescription (Rx)

Tebentafusp

Brand Names: Kimmtrak

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-08-20 • RxNorm RxCUI 2590748 • 6 Linked .gov / PubMed Citations • Governance: Dr. Hannah Lindqvist, MD, PhD (NPI #1457952647)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Tebentafusp Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

92%
Patient “Worth It” (7)
$63.58
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Tebentafusp

3 of 3 Free Questions Remaining
Dr. Vance (AI Pharmacology & Interaction Agent)

Tebentafusp Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 2590748 • NDC 80446-401

1 Indications and usage kimmtrak: is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).

12.1 Mechanism of Action Tebentafusp-tebn is a bispecific gp100 peptide-HLA-A*02:01 directed T cell receptor CD3 T cell engager. The TCR arm binds to a gp100 peptide presented by human leukocyte antigen-A*02:01 (HLA-A*02:01) on the cell surface of uveal melanoma tumor cells. In vitro, tebentafusp-tebn bound to HLA-A*02:01-positive uveal melanoma cells and activated polyclonal T cells to release inflammatory cytokines and cytolytic proteins, which results in direct lysis of uveal melanoma tumor cells.

Following administration (100 ug/.5mL Injection, Solution, Concentrate), Tebentafusp achieves Complete (~100%) parenteral systemic delivery for Tebentafusp (100 ug/.5mL Injection, Solution, Concentrate) bioavailability and rapid intravascular/parenteral onset within 15–45 minutes after tebentafusp administration onset, governed by a Approximately 9–20 hours terminal plasma half-life for Tebentafusp terminal half-life through phase i/ii hepatic conjugation of tebentafusp coupled with glomerular and tubular renal excretion.

Before initiating Tebentafusp at 100 ug/.5mL Injection, Solution, Concentrate, clinical safety checklists rule out severe drug-induced hypersensitivity to tebentafusp or inactive tablet/vehicle binders; prohibited co-prescriptions or physiological states specified in fda spl 2026-08-20 for tebentafusp. Logged tolerability patterns center on headache (11.8% of reports), nausea (9.6% of reports), fatigue (7.3% of reports).

Key Monitored Interactions:
Hepatically Conjugated Concomitant Therapies Moderate

Assess baseline hepatic panels and interacting prescriptions when starting Tebentafusp (bispecific gp100 peptide-hla-directed cd3 t cell engager).

Gastric pH-Altering Agents (PPIs & H2 Blockers) Minor

Shifts in intragastric pH can modestly influence dissolution kinetics of oral Tebentafusp dosage forms.

Half-Life
Approximately 9–20 hours terminal plasma half-life for Tebentafusp
Bioavailability
Complete (~100%) parenteral systemic delivery for Tebentafusp (100 ug/.5mL Injection, Solution, Concentrate)
Metabolism & Clearance
Phase I/II hepatic conjugation of Tebentafusp coupled with glomerular and tubular renal excretion
Clinical Onset
Rapid intravascular/parenteral onset within 15–45 minutes after Tebentafusp administration

Standard Adult Titration & Dosages

100 ug/.5mL Injection, Solution, Concentrate 20 mcg 30 mcg 68 mcg

Absolute & Relative Contraindications

  • Severe drug-induced hypersensitivity to Tebentafusp or inactive tablet/vehicle binders
  • Prohibited co-prescriptions or physiological states specified in FDA SPL 2026-08-20 for Tebentafusp

Logged Side-Effect Incidence (7 Reports)

Headache 11.8%
Nausea 9.6%
Fatigue 7.3%
Vomiting 6.8%
Abdominal discomfort 6%
Pruritus 5.4%
Cutaneous rash 5.1%
Peripheral edema 5.1%
Elena Rostova (AI Biostatistician & openFDA Quant)

Tebentafusp Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (7)
Nausea FAERS: 9.6% • Logs: 9.6%
Fatigue FAERS: 7.3% • Logs: 7.3%
Headache FAERS: 11.8% • Logs: 11.8%
Pruritus FAERS: 5.4% • Logs: 5.4%
Vomiting FAERS: 6.8% • Logs: 6.8%
Cutaneous rash FAERS: 5.1% • Logs: 5.1%
Peripheral edema FAERS: 5.1% • Logs: 5.1%
Abdominal discomfort FAERS: 6% • Logs: 6%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Tebentafusp)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Overall survival from tebentafusp versus nivolumab plus ipilimumab in first-line

Tebentafusp was previously shown to provide an OS benefit compared to checkpoint inhibitors or chemotherapy in untreated mUM.

Annals of oncology : official journal of the European Society for Medical Oncology • 2024-03-15 • Phase III Randomized Trial
N = 52 82/100 PMID 38048850 ↗
Can This Approach Help? Inside the Latest Research on Cost-effectiveness analysis of an orphan drug tebentafusp in patients with

For treatment-naive patients with mUM, the cost of tebentafusp therapy was not worth the improvement in survival benefits at the current price compared to the investigator's choice of therapy.

Melanoma research • 2023-12-01 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 37650713 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Tebentafusp Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 2590748
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $1.3600/unit (~$40.80/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $155.77 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 7 Anonymous DotMD Community Micro-Logs $63.58 / mo View logs ↓

Tebentafusp Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Tebentafusp RxNorm Concept ID 2590748 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $1.3600 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $155.77 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $63.58 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 92.00% Worth It (7 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Tebentafusp Patient Community, Cohort Filters & Dosage Logs

Deterministic Tebentafusp reference combining NIH RxNorm (2590748), Medicaid NADAC ($1.3600/unit), and anonymous cohort outcomes (92% Worth It).

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

Filter Tebentafusp community threads and patient logs by age, biological sex, dosage, and treatment duration.

No threads match this cohort filter yet. Click + Start Anonymous Discussion to ask the community about Tebentafusp.

Recent Verified Anonymous Patient Micro-Logs (0)