Last reviewed · How we verify
TEBENTAFUSP
At a glance
| Generic name | TEBENTAFUSP |
|---|---|
| Drug class | Bispecific gp100 Peptide-HLA-directed CD3 T Cell Engager [EPC] |
| Modality | Recombinant protein |
| Phase | FDA-approved |
| First approval | 2022 |
Approved indications
Boxed warnings
- WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated [(see Dosage and Administration (2.2) , see Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated ( 2.2 , 5.1 ).
Common side effects
- Cytokine release syndrome
- Rash
- Pyrexia
- Fatigue
- Nausea
- Chills
- Abdominal pain
- Edema
- Hypotension
- Dry skin
- Headache
- Vomiting
Key clinical trials
- Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma (PHASE2)
- Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors (PHASE1, PHASE2)
- Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma (PHASE2)
- Adjuvant Tebentafusp in High Risk Ocular Melanoma (PHASE3)
- Neoadjuvant Tebentafusp for Uveal Melanoma (PHASE2)
- Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma (PHASE2)
- Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM) (PHASE3)
- Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TEBENTAFUSP CI brief — competitive landscape report
- TEBENTAFUSP updates RSS · CI watch RSS