Tukysa

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tucatinib

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

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.

This EPAR was last updated on 27/09/2022

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)
  • Breast Neoplasms
  • Neoplasm Metastasis
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.

Publication details
Marketing-authorisation holder
Seagen B.V.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
11/02/2021
Contact address

Evert Van De Beekstraat 1/104
1118 CL Schiphol
Netherlands

Product information

11/02/2022 Tukysa - EMEA/H/C/005263 - N/0006

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Select ‘available languages’ to access the language you need.

 

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

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.

Assessment history

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