Brigatinib

Brigatinib (Alunbrig, Takeda Pharma A/S) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: ALK (2).
Approved indications of Brigatinib
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer2
ALK fusion
Monotherapy
2L
advanced
Previously treated with crizotinib
ALK fusion
Monotherapy
Any line
advanced
No prior ALK inhibitor
Full text of section 4.1 (therapeutic indications)

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 ALK-positive advanced NSCLC previously treated with crizotinib.

Label history

11 changes to the Alunbrig label since 2019, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes