KIMMTRAK
KIMMTRAK (tebentafusp-tebn) is a bispecific gp100 peptide-HLA-directed CD3 T cell engager. It is indicated for the treatment of adult patients with unresectable or metastatic uveal melanoma. This therapy is specifically designated for patients who are HLA-A*02:01-positive.
How KIMMTRAK Works
Tebentafusp-tebn works by bridging T cells and tumor cells to facilitate an immune response. The molecule's T cell receptor arm binds to a gp100 peptide presented by HLA-A*02:01 on the surface of uveal melanoma cells. This interaction activates polyclonal T cells to release inflammatory cytokines and cytolytic proteins, resulting in the direct lysis of the tumor cells.
Details
- Status
- Prescription
- First Approved
- 2022-01-25
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
KIMMTRAK Approval History
What KIMMTRAK Treats
1 indicationsKIMMTRAK is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Uveal Melanoma
KIMMTRAK Boxed 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 fol...
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 ).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KIMMTRAK FDA Label Details
ProIndications & Usage
FDA Label (PDF)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 .
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 a...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.