This medicine is authorised for use in the European Union.


Alunbrig is a cancer medicine that is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). It is used in patients who have not been treated before with a medicine of the ALK inhibitor class or who have been treated before with the ALK-inhibitor crizotinib.

Alunbrig is only used if the NSCLC is ‘ALK-positive’, which means that the cancer cells have certain changes affecting the gene that makes a protein called ALK (anaplastic lymphoma kinase).

Alunbrig contains the active substance brigatinib.

This EPAR was last updated on 22/09/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
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
Takeda Pharma A/S
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Delta Park 45
2665 Vallensbaek Strand

Product information

24/07/2023 Alunbrig - EMEA/H/C/004248 - R/0049

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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

Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.

Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase ALKpositive advanced NSCLC previously treated with crizotinib.

Assessment history

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