Corporate Member Update: BeiGene- BRUKINSA® (zanubrutinib) New FDA Approvals

BRUKINSA® (zanubrutinib) capsules, for oral use – new FDA approvals

BeiGene USA, Inc. is happy to announce two new approvals of BRUKINSA® (zanubrutinib) capsules, for oral use by the U.S. Food and Drug Administration (FDA), for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) (on August 31, 2021) and for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen (on September 14, 2021). The MZL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

Please see Important Safety Information below and click https://www.brukinsa.com/prescribing-information.pdf to access the Full Prescribing
Information for BRUKINSA.

To read the full press release, click here!