ALUNBRIG (Takeda Pharmaceuticals Australia Pty Ltd)
Product name
ALUNBRIG
Date registered
Evaluation commenced
Decision date
Approval time
190 working days (255)
Active ingredients
brigatinib
Registration type
NCE/NBE
Indication
ALUNBRIG (film-coated tablet) is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. The approval of this medicine is based on objective response rate and duration of response in a non-comparative study.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.