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BRUKINSA (Beigene Aus Pty Ltd)
Product name
BRUKINSA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
250 (255 working days)
Active ingredients
zanubrutinib
Registration type
NCE/NBE
Indication
Mantle cell lymphoma (MCL)
BRUKINSA (capsule) is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior 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