FDA Approves Label Revision for BRUKINSA® (zanubrutinib) in Chronic Lymphocytic Leukemia (CLL)

BeiGene, Ltd. has received approval from the U.S. Food and Drug Administration (FDA) for a label update for BRUKINSA® (zanubrutinib). This update is based on superior progression-free survival (PFS) results from the Phase 3 ALPINE trial, which compared BRUKINSA with IMBRUVICA® (ibrutinib) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Dr. Mehrdad Mobasher, Chief Medical Officer, Hematology at BeiGene, highlighted that the ALPINE trial is the first to demonstrate PFS superiority in a head-to-head comparison against ibrutinib in CLL. This label update follows the earlier approval of BRUKINSA for CLL in the U.S. in 2023. The updated label incorporates data with a median follow-up of 31 months, showing that BRUKINSA achieved superior PFS compared to ibrutinib in patients with relapsed or refractory CLL. Additionally, BRUKINSA demonstrated a favorable cardiac safety profile.

Extended follow-up data from the ALPINE trial, presented at the 65th Annual ASH Meeting and Exposition, demonstrated sustained PFS benefit with BRUKINSA at a median follow-up of 39 months. The data revealed continued superiority over ibrutinib, with durable PFS benefits observed across subgroups, including patients with specific genetic mutations.

BRUKINSA's safety profile, consistent with previous analyses, showed lower rates of cardiovascular events compared to ibrutinib. The most commonly reported treatment emergent adverse events with BRUKINSA included COVID-19-related issues, neutropenia, hypertension, and upper respiratory tract infection.

BRUKINSA is approved in over 65 countries for selected indications, including the U.S., China, EU, Great Britain, Canada, Australia, South Korea, and Switzerland. In the U.S., it is approved for CLL, small lymphocytic lymphoma, Waldenström’s macroglobulinemia, mantle cell lymphoma, and relapsed or refractory marginal zone lymphoma.

CLL is a life-threatening cancer, the most common type of leukemia in adults, with an estimated 18,740 new cases in the U.S. in 2023. BRUKINSA, a BTK inhibitor, offers complete and sustained inhibition of the BTK protein, demonstrating efficacy and a differentiated safety profile in the treatment of CLL and related conditions.

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