BRUKINSA Approved in the U.S. for Chronic Lymphocytic Leukemia
BeiGene, a global biotechnology company, today announced that the United States Food and Drug Administration (FDA) has approved its Bruton’s tyrosine kinase inhibitor (BTKi) BRUKINSA (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
“With four US approvals in just over three years and demonstrated superiority versus ibrutinib in the final progression-free survival (PFS) analysis of the ALPINE trial, we believe BRUKINSA is well-positioned to become the BTKi of choice across multiple indications,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “We’re grateful to the patients who participated in the ALPINE and SEQUOIA studies; and with this new approval, we’re excited to expand our impact to even more patients.”
The pre-defined final PFS analysis of the ALPINE study demonstrating superior efficacy and a favorable cardiac safety profile for BRUKINSA versus IMBRUVICA in patients with R/R CLL, was presented in a late-breaking session at the 64th Annual American Society for Hematology (ASH) Meeting and published simultaneously in The New England Journal of Medicine. With a median follow-up of 29.6 months, BRUKINSA demonstrated superior PFS compared with ibrutinib in patients with R/R CLL (HR: 0.65 [95% CI, 0.49-0.86] P=.0024, for both investigator and IRC). Additionally, BRUKINSA demonstrated a favorable cardiac safety profile, with significantly lower rates of atrial fibrillation/flutter (5.2% vs 13.3%) and zero deaths due to cardiac disorders with BRUKINSA vs. six with ibrutinib (0% vs 1.9%).4,5
Jennifer R. Brown, M.D., Ph.D., Director of the CLL Center of the Division of Hematologic Malignancies at Dana-Farber Cancer Institute, commented, “We have seen striking data from the BRUKINSA 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. 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.”
“Thanks to research that has delivered innovative and effective medicines, people with CLL can remain on therapy for years so tolerability is an important consideration. I’m pleased that the approval of zanubrutinib provides a new BTKi option for people with CLL/SLL, with demonstrated efficacy as well as being very well tolerated long-term,” said Brian Koffman, M.D., Chief Medical Officer and Executive Vice-President at CLL Society.
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