Quick answers
- What is Tebentafusp used for?
- The FDA-approved label (Kimmtrak, Immunocore Commercial LLC, August 20, 2026) says: “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 ).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tebentafusp have a boxed warning?
- Yes. The FDA label for Kimmtrak has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Tebentafusp?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tebentafusp been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tebentafusp?
- 1 company lists prescription products of Tebentafusp in the FDA NDC Directory, including Immunocore Commercial LLC.
What Tebentafusp is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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 ).
— FDA label: Kimmtrak, Immunocore Commercial LLC, effective August 20, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, solution, concentrate |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Kimmtrak |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Immunocore Commercial LLC1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761228 KIMMTRAK | Immunocore Ltd | January 25, 2022 | 2, latest June 27, 2024 2024: Labeling · 2022: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2590748, 2590754 |
|---|---|
| SPL set ID of the quoted label | 24a49f57-d2fc-4ffe-9eb1-fe0460c6b067 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761228 |
| Active ingredients (FDA) | TEBENTAFUSP |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Kimmtrak, Immunocore Commercial LLC, effective August 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →