BRUKINSA (Beigene Aus Pty Ltd)
Product name
BRUKINSA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
193 (255 working days)
Active ingredients
zanubrutinib
Registration type
EOI
Indication
Marginal Zone Lymphoma (MZL)
BRUKINSA is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one-prior anti-CD20-based therapy.
This indication was approved via the provisional approval pathway, based on objective response rate. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration