Zanubrutinib Earns Chinese Approvals in CLL/Small Lymphocytic Lymphoma

Zanubrutinib (Brukinsa) has been approved by China’s National Medical Products Administration for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as well as those with Waldenström macroglobulinemia, according to a press release from BeiGene.¹

The FDA previously approved zanubrutinib for treating patients with CLL and SLL in January 2023.

The agency approved a total of 4 zanubrutinib applications including 2 supplemental new drug applications for adult patients with treatment-naïve CLL/SLL and Waldenström macroglobulinemia and 2 supplemental applications that converted from conditional approval to full approval.

The approval for the CLL/SLL indication was supported by data from the phase 3 SEQUIOA trial (NCT03336333). In the trial, the median progression-free survival was not reached (95% CI, not evaluable [NE]-NE) with zanubrutinib plus bendamustine vs 33.7 months (95% CI, 28.1-NE) with bendamustine plus rituximab (Rituxan) in patients with previously untreated CLL or small lymphocytic leukemia (Hazard ratio, 0.42; 95% CI, 0.28-0.63; P <.0001).²

Supporting data for the approval of zanubrutinib in Waldenström macroglobulinemia came from the phase 3 ASPEN trial (NCT03053440). Patients receiving zanubrutinib had a very good partial response rate of 28% compared with 19% among those receiving ibrutinib (Imbruvica).³

“[Zanubrutinib] has been recommended as the preferred regimen of multiple subtypes of lymphoma in both national and international guidelines,” Ma Jun, director of the Harbin Institute of Hematology & Oncology and the chief supervisor of the Supervisory Committee at the Chinese Society of Clinical Oncology, said in the press release. “With these important approvals, [zanubrutinib] now becomes the only approved new-generation [Bruton tyrosine kinase] inhibitor in China for the first-line treatment of adult patients [with CLL/SLL] and [Waldenström macroglobulinemia]….”

The FDA previously approved zanubrutinib for the treatment of patients with CLL and SLL based on findings from the SEQUIOA trial in January 2023. The agency also approved zanubrutinib for Waldenström macroglobulinemia based on findings from the ASPEN trial in September 2021. The European Commission also approved zanubrutinib for patients with CLL in November 2022.⁴

References

1. BeiGene receives new approvals for BRUKINSA® (zanubrutinib) in China. News release. BeiGene. May 6, 2023. Accessed May 10, 2023. bit.ly/3NYkbOA
2. FDA approves zanubrutinib for chronic lymphocytic leukemia or small lymphocytic lymphoma. News release. FDA. January 19, 2023. Accessed May 10, 2023. http://bit.ly/3J2ZQoU
3. U.S. FDA grants BRUKINSA® (zanubrutinib) approval in Waldenström’s macroglobulinemia. News release. BeiGene. September 1, 2021. Accessed May 10, 2023. https://bwnews.pr/3gUe6kZ
4. BeiGene receives European Commission approval for BRUKINSA® (zanubrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL). News release. BeiGene. November 17, 2022. Accessed May 10, 2023. bit.ly/3An74i3