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U.S. FDA Grants BRUKINSA® (Zanubrutinib) Approval in Waldenström’s Macroglobulinemia on September 01, 2021

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 In science and medicine, information is constantly changing and may become out-of-date as new data emerge.

While not directly related to CLL, this second FDA-approved indication is another reason to anticipate that zanubrutinib will soon be an approved option for chronic lymphocytic leukemia (CLL) patients.  And that is good news for us. The more treatment choices we have, the better.

Zanubrutinib is a BTK inhibitor, similar to the approved CLL drugs acalabrutinib and ibrutinib. It is already approved to treat CLL in China.

As it has been FDA approved since November 2019 for mantle cell lymphoma (MCL), it could already be used “off label” to treat CLL. In fact, it is already being prescribed by some CLL experts who choose it for some of their patients because of its side effect profile and its lack of interaction with PPIs (proton pump inhibitors), such as omeprazole or Prilosec.

Find the official press release here: U.S. FDA Grants BRUKINSA® (Zanubrutinib) Approval in Waldenström’s Macroglobulinemia.

Stay strong. We are all in this together.

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