The US Food and Drug Administration (FDA) has approved Brukinsa® (zanubrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Zanubrutinib, a next-generation BTK inhibitor, was approved based on data from the phase 3 SEQUOIA trial and the phase 3 ALPINE trial.
The SEQUOIA trial included 479 patients with previously untreated CLL/SLL. They were randomly assigned to receive either zanubrutinib at 160 mg orally twice daily until disease progression or unacceptable toxicity (n=241) or bendamustine plus rituximab (BR) for 6 cycles (n=238). At a median follow-up of 25 months, the median progression-free survival was not reached in the zanubrutinib arm and was 33.7 months in the BR arm (hazard ratio [HR], 0.42; 95% CI, 0.28-0.63; P <.0001).
The ALPINE trial included 652 patients with relapsed or refractory CLL/SLL. They were randomly assigned to receive either zanubrutinib at 160 mg orally twice daily (n=327) or ibrutinib at 420 mg orally once daily (n=325) until disease progression or unacceptable toxicity. The objective response rate was 80% in the zanubrutinib arm and 73% in the ibrutinib arm (response rate ratio, 1.10; 95% CI, 1.01-1.20; P =.0264). At a median follow-up of 14.1 months, the median duration of response was not reached in either arm.
“We have seen striking data from the Brukinsa development program demonstrating significant and consistent efficacy across CLL patient subtypes, including the high-risk del17p/TP53 mutated population, and regardless of treatment setting,” said Jennifer R. Brown, MD, PhD, director of the CLL Center at Dana-Farber Cancer Institute and investigator on the SEQUOIA and ALPINE trials. “With extensive follow-up across the CLL development program and the combined results from the SEQUOIA and ALPINE trials, Brukinsa is established as a new standard of care for CLL.”
Across all clinical trials with zanubrutinib, the most common adverse events reported were decreased neutrophil count (42%), upper respiratory tract infection (39%), decreased platelet count (34%), hemorrhage (30%), and musculoskeletal pain (30%). Thirteen percent of patients developed second primary malignancies, including non-skin carcinomas. Atrial fibrillation and grade 3 or higher ventricular arrhythmias were reported in 3.7% and 0.2% of patients, respectively.
Brukinsa is also approved for the treatment of adults with mantle cell lymphoma who have received at least 1 prior therapy, Waldenström’s macroglobulinemia, and relapsed or refractory marginal zone lymphoma in patients who have received at least 1 anti-CD20-based regimen. The product is supplied as 80 mg capsules in 120-count bottles.
- FDA approves zanubrutinib for chronic lymphocytic leukemia or small lymphocytic lymphoma. News release. BeiGene USA, Inc. Accessed January 20, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanubrutinib-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma.
- Brukinsa® approved in the US for chronic lymphocytic leukemia. News release. BeiGene. Accessed January 20, 2023. https://www.businesswire.com/news/home/20230119005888/en/BRUKINSA%C2%AE-Approved-in-the-U.S.-for-Chronic-Lymphocytic-Leukemia.
- Brukinsa. Package insert. BeiGene USA, Inc; 2022. Accessed January 20, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213217s007lbl.pdf.
This article originally appeared on MPR