Prescription medicine
Tebentafusp Brand names: Kimmtrak
Tebentafusp (Kimmtrak) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the tebentafusp FDA label on DailyMed (effective August 20, 2026); every tebentafusp label on DailyMed.
Highlights of the record
FDA label of August 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 ).
Used for
From the label: indications and usageKIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
Forms and strengths
- 0.5ml
Injection (solution) (concentrate).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 581 through July 30, 2026
What is tebentafusp used for?
From the label: indications and usageKIMMTRAK 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 pharmacologic class: Bispecific gp100 Peptide-HLA-directed CD3 T Cell Engager.
Source: FDA drug label (KIMMTRAK), Immunocore Commercial LLC, effective August 20, 2026 (SPL set 24a49f57-d2fc-4ffe-9eb1-fe0460c6b067), via openFDA; the full label on DailyMed
What does the patient leaflet for tebentafusp say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about KIMMTRAK?KIMMTRAK can cause serious side effects that can be severe or, life threatening, and usually happens within the first three infusions. These side effects include: Cytokine Release Syndrome (CRS). Tell your healthcare provider right away if you get any of the following symptoms: fever tiredness or weakness vomiting chills nausea low blood pressure dizziness and light headedness headache wheezing and trouble breathing rash Your healthcare provider will check for these problems during treatment with KIMMTRAK. Your healthcare provider may temporarily stop or completely stop your treatment with KIMMTRAK, if you have severe side effects. See “ What are the possible side effects of KIMMTRAK? ” for more information about side effects.
Source: FDA drug label (KIMMTRAK), Immunocore Commercial LLC, effective August 20, 2026 (SPL set 24a49f57-d2fc-4ffe-9eb1-fe0460c6b067), via openFDA; the full label on DailyMed
Is there a generic for tebentafusp (Kimmtrak)?
No generic tebentafusp is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for tebentafusp?
The FDA Adverse Event Reporting System holds 581 reports that list tebentafusp among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 102 are coded as a death and 195 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Tebentafusp side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other