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EMA Product

Alunbrig

Product approved by European Medicines Agency (EU)

Basic Information

Alunbrig

Regulatory Information

EMEA/H/C/004248

Authorised

November 22, 2018

September 19, 2018

10

September 22, 2023

Company Information

Denmark

Delta Park 45 2665 Vallensbaek Strand

Takeda Pharma A/S

Active Substances Detail

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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.

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