U.S. FDA Approves Tablet Formulation of BeOne’s BRUKINSA ® for All Approved Indications11.6.2025 23:05:00 EEST | Press release
BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of BRUKINSA® (zanubrutinib) for all five approved indications. BRUKINSA remains the leader in new chronic lymphocytic leukemia (CLL) patient starts across all lines of therapy in the U.S., and for the first time, has become the overall BTK inhibitor market share leader.1 BRUKINSA tablets have the same efficacy and safety as BRUKINSA capsules based on the results of two single-dose, open-label, randomized Phase 1 crossover studies of healthy adults designed to establish bioequivalence. BRUKINSA is the only BTK inhibitor to offer the flexibility of once or twice daily dosing, with the ability to tailor the schedule to patient needs. It also continues to be the only BTK inhibitor with recommended dosing for severe hepatic impairment. “BRUKINSA’s leadership in the U.S. underscores the trust physicians