Tebentafusp
Other Antineoplastic Agents
Sold as Kimmtrak
- Drug class
- Other Antineoplastic Agents
- Availability
- See label
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 3
Overview
Tebentafusp is an active pharmaceutical ingredient in the Other Antineoplastic Agents group (L01XX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 1 | May 1, 2026 |
| EU European Union | EMA | 1 | December 9, 2025 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
GBUnited Kingdom· MHRA
1 product
Uses
KIMMTRAK is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
How to take
EUEuropean Union· EMA
1 product
Uses
KIMMTRAK is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
How to take
CACanada· Health Canada
1 product
Uses
KIMMTRAK (tebentafusp) is indicated for: the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. 1 Pediatrics Pediatrics (˂ 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Geriatrics (≥ 65 years of age): Of the 410 patients with metastatic uveal melanoma treated with KIMMTRAK, 175 (43%) were 65 years of age and older and 38 (9%) were 75 years of age and older. Evidence from clinical studies suggests that use in the geriatric population is associated with no overall differences in safety or effectiveness.
How to take
Sources & citations
- [1]MHRA (UK) · PLGB367810001 · revised May 1, 2026
- [2]European Medicines Agency · EMEA/H/C/004929 · revised December 9, 2025
- [3]Health Canada (DPD) · 02527588 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.