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EMA Product

Tukysa

Product approved by European Medicines Agency (EU)

Basic Information

Tukysa

Regulatory Information

EMEA/H/C/005263

Authorised

February 11, 2021

December 10, 2020

9

April 3, 2025

Company Information

Belgium

Boulevard de la Plaine 17 1050 Bruxelles

Pfizer Europe MA EEIG

Drug Classification

Additional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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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