FDA Approves Zanubrutinib for Adults With Chronic Lymphocytic Leukemia

Beigene announced this week the FDA approval of its Bruton’s tyrosine kinase inhibitor (BTKi) zanubrutinib for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The FDA approval is based on results from 2 global phase 3 trials ALPINE and SEQUOIA, in which zanubrutinib demonstrated superior efficacy and improved safety profile over ibrutinib and bendamustine plus rituximab for CLL/SLL in first-line and relapsed/refractory treatment settings.

Key results from the trials include:

• Superior progression-free survival benefit with zanubrutinib compared with bendamustine plus rituximab, (HR 0.42, [95% CI: 0.28, 0.63], P < .0001) after a median 26.2 months follow up
• Overall response rate for zanubrutinib vs ibrutinib in the relapsed/refractory (R/R) treatment setting (ORR 80.4% vs 72.9%, P = .0264)

“With extensive follow-up across the CLL development program and the combined results from the SEQUOIA and ALPINE trials, [zanubrutinib] is established as a new standard of care for CLL,” said Jennifer R. Brown, MD, PhD, director of the cll center of the division of hematologic malignancies at Dana-Farber Cancer Institute, in a press release. 

Zanubrutinib was already indicated for mantle cell lymphoma, Waldenström's macroglobulinemia, and marginal zone lymphoma.

Reference:
BRUKINSA® Approved in the US for Chronic Lymphocytic Leukemia [news release]. Business Wire. January 19, 2023. Accessed January 20, 2023. https://www.businesswire.com/news/home/20230119005888/en/