Tukysa
tucatinib
Table of contents
Overview
Tukysa is a cancer medicine that is used to treat breast cancer that is locally advanced or metastatic (has spread to other parts of the body) and when it is HER2-positive. This means the cancer cells produce a protein on their surface, HER2, which stimulates the growth of the cancer.
Tukysa is used with two other medicines, capecitabine and trastuzumab, and is used after at least 2 other treatments for HER2-positive cancer have already been tried.
The active substance in Tukysa is tucatinib.
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Tukysa : EPAR - Medicine overview (PDF/119.14 KB)
First published: 18/02/2021
EMA/50289/2021 -
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Tukysa : EPAR - Risk-management-plan summary (PDF/126.02 KB)
First published: 18/02/2021
Last updated: 29/03/2023
Authorisation details
Product details | |
---|---|
Name |
Tukysa
|
Agency product number |
EMEA/H/C/005263
|
Active substance |
Tucatinib
|
International non-proprietary name (INN) or common name |
tucatinib
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01EH03
|
Additional 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. |
Publication details | |
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Marketing-authorisation holder |
Seagen B.V.
|
Revision |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
11/02/2021
|
Contact address |
Evert Van De Beekstraat 1/104 |
Product information
20/07/2023 Tukysa - EMEA/H/C/005263 - II/0013
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2‑positive locally advanced or metastatic breast cancer who have received at least 2 prior anti‑HER2 treatment regimens.