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

Core Insights - The U.S. FDA has approved a label update for BRUKINSA® (zanubrutinib) highlighting its superior progression-free survival (PFS) results compared to IMBRUVICA® (ibrutinib) in previously treated patients with relapsed or refractory chronic lymphocytic leukemia (CLL) [1][2] Group 1: Clinical Trial Results - The ALPINE trial is the first study to show PFS superiority in a head-to-head comparison against ibrutinib for CLL [2] - At a median follow-up of 31 months, BRUKINSA demonstrated a PFS advantage with a hazard ratio (HR) of 0.65 (95% CI, 0.49-0.86, P=.0024) compared to ibrutinib [2] - Extended follow-up data at 39 months showed sustained PFS benefit for BRUKINSA with an HR of 0.68 (95% CI, 0.53-0.86, P=0.0011) among R/R CLL patients [3] Group 2: Safety Profile - BRUKINSA exhibited a favorable cardiac safety profile with lower rates of atrial fibrillation/flutter (5.2% vs. 13.3%) and no deaths due to cardiac disorders compared to ibrutinib [2] - The overall safety profile was consistent with previous analyses, showing persistently lower rates of cardiovascular events [3] - The most common treatment-emergent adverse events (≥20%) included COVID-19-related issues, neutropenia, hypertension, and upper respiratory tract infections [3] Group 3: Regulatory and Market Presence - BRUKINSA is approved in over 65 countries, including the U.S., China, and the EU, for various indications including CLL and Waldenström's macroglobulinemia [4] - The global development program for BRUKINSA has enrolled over 5,000 subjects across 29 countries [4] Group 4: Disease Context - Chronic lymphocytic leukemia (CLL) is the most common type of leukemia in adults, with approximately 18,740 new cases expected in the U.S. in 2023 [5]