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BeiGene Announces U.S. FDA Acceptance of Supplemental New Drug Application for BRUKINSA (zanubrutinib) in Chronic Lymphocytic Leukemia

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This should be good news for CLL / SLL patients. If things go as planned, we could have FDA approval of a third irreversibly binding BTK inhibitor, zanubrutinib, before the end of the year.

Zanubrutinib is already approved in the U.S. for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (Nov. 2019) for the treatment of adult patients with Waldenström’s macroglobulinemia (W.M.) (Aug. 2021). And also for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen (Sept. 2021).

The National Comprehensive Cancer Network (NCCN) already includes zanubrutinib in its guidelines for CLL, so it is available “off label” for treatment. FDA approval will make it even more accessible with less pushback from insurance companies about payment.

While zanubrutinib is not likely to be active when either ibrutinib or acalabrutinib stops working as it binds at the same site; Resistant to one irreversibly binding BTKi almost certainly means resistance to all. However, many patients could benefit from zanubrutinib due to the possibility of better tolerance and fewer drug interactions.

Having another strong treatment option can only be good news.

Here is BeiGene’s official Press Release that details some of the exciting trial data underpinning their application.

Stay strong. We are all in this together.


Brian Koffman MDCM (retired) MS Ed (he, him, his)
Co-Founder, Executive VP, and Chief Medical Officer
CLL Society, Inc.