FDA OKs Zanubrutinib to Treat Leukemia Subtypes


Patients with chronic lymphocytic leukemia and small lymphocytic leukemia can now receive treatment with zanubrutinib following its approval by the FDA.

The FDA has approved zanubrutinib (Brukinsa) to treat patients with chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia, according to a press release from the FDA.1

The decision was supported by data from the phase 3 SEQUOIA (NCT03336333) trial which assessed zanubrutinib plus bendamustine in a population of 479 patients with previously untreated disease.

Median progression-free survival was not reached among those treated with zanubrutinib compared with 33.7 months (95% CI, 28.1-not estimable) in the bendamustine and rituximab (Rituxan) arm (HR, 0.42; 95% CI, 0.28-0.63; P < .0001).

Zanubrutinib was also evaluated vs ibrutinib (Imbruvica) as part of the phase 3 ALPINE study (NCT03734016) in patients with relapsed/refractory CLL. Among the 652 patients who were included in the study, the overall response rate was 80% (95% CI, 76%-85%) in the zanubrutinib cohort vs 73% (95% CI, 68%-78%) in the ibrutinib cohort (response ratio, 1.10; 95% CI, 1.01-1.20; P = .0264).

The median duration of response was not reached in either arm.

“We have seen striking data from the [zanubrutinib] development program demonstrating significant and consistent efficacy across CLL patient sub-types, including the high-risk del17p/TP53 mutated population, and regardless of treatment setting,” Jennifer R. Brown, MD, PhD, director of the CLL Center of the Division of Hematologic Malignancies at Dana-Farber Cancer Institute in Boston, said in a press release from developer BeiGene.2 “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.”


  1. FDA approves zanubrutinib for chronic lymphocytic leukemia or small lymphocytic lymphoma. News release. FDA. January 19, 2022. Accessed January 19, 2022. http://bit.ly/3J2ZQoU
  2. BRUKINSA® approved in the U.S. for chronic lymphocytic leukemia. News release. BeiGene. January 19, 2023. Accessed January 19, 2023. http://bit.ly/3QT6lfB
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