Kimmtrak

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tebentafusp

Authorised
This medicine is authorised for use in the European Union.

Overview

Kimmtrak is a medicine used to treat adults with a type of eye cancer called ‘uveal melanoma’. It is used when the uveal melanoma cannot be removed by surgery or has spread to other parts of the body.

Uveal melanoma is rare, and Kimmtrak was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 February 2021.

This EPAR was last updated on 22/04/2022

Authorisation details

Product details
Name
Kimmtrak
Agency product number
EMEA/H/C/004929
Active substance
tebentafusp
International non-proprietary name (INN) or common name
tebentafusp
Therapeutic area (MeSH)
Uveal Neoplasms
Anatomical therapeutic chemical (ATC) code
L01
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Immunocore Ireland Limited
Date of issue of marketing authorisation valid throughout the European Union
01/04/2022
Contact address

Unit 1 Sky Business Centres Unit 21
Block Port Tunnel Business Park
Clonshaugh Dublin 17
Dublin D17 FY82
Ireland

Product information

01/04/2022 Kimmtrak - EMEA/H/C/004929 -

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment history

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