BRUKINSA (Beigene Aus Pty Ltd)
Product name
BRUKINSA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
240 (255 working days)
Active ingredients
zanubrutinib
Registration type
NCE/NBE
Indication
Waldenström's Macroglobulinemia (WM)
BRUKINSA (capsule) is indicated for the treatment of adult patients with Waldenström's Macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.