BeOne says FDA approves table formulation of Brukinsa for approved indications

BeOne Medicines (ONC) announced that the U.S. Food and Drug Administration has approved a new tablet formulation of BRUKINSA for all five approved indications. BRUKINSA remains the leader in new chronic lymphocytic leukemia 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. 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 and patients have placed in its differentiated clinical profile,” said Matt Shaulis, General Manager of North America, BeOne. “With this new tablet formulation, we are making treatment simpler and more convenient-an important step forward for patients facing certain B-cell cancers.”