Molecule
Tebentafusp 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. It is available as injection for intravenous use. MedsAcross supplies Tebentafusp for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
Recommended dosage: 20 mcg intravenously on Day 1, 30 mcg intravenously on Day 8, 68 mcg intravenously on Day 15, and 68 mcg intravenously once every week thereafter. Dilute and administer by intravenous infusion over 15-20 minutes. See Full Prescribing Information for instructions on preparation and administration of the diluted solution for intravenous infusion. Dosage interruption or permanent discontinuation may be required based on individual safety and tolerability.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
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 [ ]. WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Skin reactions: Rash, pruritus, and cutaneous edema occurred in patients treated with KIMMTRAK. If skin reactions occur, treat based on persistence and severity of symptoms. Elevated liver enzymes: Elevations in liver enzymes occurred in patients treated with KIMMTRAK. Monitor ALT, AST, and total bilirubin. Embryo-Fetal toxicity: May cause fetal harm. Advise patients of reproductive potential of the potential risk to the fetus and to use effective contraception.
Source: US FDA prescribing information
The following serious adverse reactions are discussed in greater detail in other sections of the label: Cytokine Release Syndrome Skin Reactions Elevated Liver Enzymes The most common adverse reactions (occurring in ≥ 30%) are cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache and vomiting. The most common laboratory abnormalities (occurring in ≥50%) are decreased lymphocyte count, increased creatinine, increased glucose, increased aspartate aminotransferase, increased alanine aminotransferase, decreased hemoglobin, and decreased phosphate.
Source: US FDA prescribing information
Store KIMMTRAK vials in the original carton refrigerated at 2°C to 8°C (36°F to 46°F) and protect from light until time of use. Do not freeze. Do not shake.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Tebentafusp, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Kimmtrak 100 mcg/0.5 mL injectionIntravenous Cold chain | Immunocore Commercial | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Tebentafusp and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Tebentafusp, including Kimmtrak.
Yes. The US FDA first approved Tebentafusp on 25 January 2022, according to Drugs@FDA.
Yes. Tebentafusp has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Tebentafusp must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tebentafusp is classified under ATC code L01XX75 (Tebentafusp).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.