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U.S. FDA Grants BRUKINSA® (Zanubrutinib) Accelerated Approval in Relapsed or Refractory Marginal Zone Lymphoma

This content was current as of the date it was released. In science and medicine, information is constantly changing and may become out-of-date as new data emerge.

Zanubrutinib is an irreversible BTK inhibitor similar to ibrutinib and acalabrutinib, both of which are already approved to treat chronic lymphocytic leukemia.

Recent trials suggest that zanubrutinib may have advantages for CLL patients over the approved medications. Since it is approved for MCL (Mantle Cell Lymphoma), a cousin of B-cell lymphoma, it is already being used “off label” to treat CLL, so this approval changes nothing for CLL patients, except that it means that more hematologists will become familiar with it and it is hopefully moving closer to approval in CLL. And both of those are good things.

Here is a link to the FDA’s approval on Sep. 14, 2021.

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