European Commission Approves Zanubrutinib for Treatment of CLL


The European Commission based its approval of zanubrutinib for the management of chronic lymphocytic leukemia on data from the phase 3 SEQUOIA trial and the phase 3 ALPINE trial.

Zanubrutinib (Brukinsa) has been granted approval from the European Commission for use in adult patients with chronic lymphocytic leukemia (CLL), according to a press release from BeiGene.1

The designation was supported by findings from 2 phase 3 trials, in which zanubrutinib demonstrated superior efficacy compared with bendamustine (Bendeka) plus rituximab (Rituxan) among patients with previously untreated CLL in the phase 3 SEQUOIA trial (NCT03336333) and with ibrutinib (Imbruvica) among those with relapsed or refractory CLL in the phase 3 ALPINE trial (NCT03734016).

In the ALPINE trial, zanubrutinib yielded an overall response rate of 80.4% vs 72.9% among patients who received ibrutinib. The 1-year sustained response rates among patients receiving zanubrutinib and ibrutinib, respectively, were 90% and 78%. Additionally, topline results from the final progression-free survival (PFS) analysis indicated that zanubrutinib produced superior PFS compared with ibrutinib. Data from both trials demonstrated that the occurrence of adverse effects was consistent with the overall safety profile of zanubrutinib.

“[Zanubrutinib] has demonstrated clinically meaningful improvements as a next-generation [Bruton tyrosine kinase inhibitor (BTKi)] over the first generation BTKi, and is proven to be significantly more effective and tolerable,” Clemens Wendtner, MD, a professor and head of Hematology and Oncology at Munich Clinic, an academic teaching hospital of the University of Munich, Germany, said in the press release.

The FDA previously approved zanubrutinib for patients with relapsed/refractory marginal zone lymphoma following prior treatment with at least 1 anti–CD20-based regimen in September 2021 based on results from the phase 2 MAGNOLIA trial (NCT03846427).2


  1. BeiGene receives European Commission approval for BRUKINSA® (zanubrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL). News release. BeiGene, Ltd. November 17, 2022. Accessed November 18, 2022.
  2. U.S. FDA grants BRUKINSA® (Zanubrutinib) accelerated approval in relapsed or refractory marginal zone lymphoma. News release. BeiGene, Ltd. September 15, 2021. Accessed November 18, 2022.
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