By Fineline Cube 
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that it has received approval from the US Food and Drug Administration (FDA) for a new tablet formulation of Brukinsa (zanubrutinib) across all five approved indications.
FDA Approval Basis
The FDA decision was supported by results from two open-label, randomized, single-dose, Phase I crossover studies. These studies confirmed the bioequivalence of the tablet formulation to the existing capsule formulation in healthy adult subjects, demonstrating comparable efficacy and safety. The tablet is smaller and film-coated for easier swallowing.
Drug Mechanism and Advantages
Brukinsa is an oral, small-molecule Bruton’s tyrosine kinase (BTK) inhibitor designed to achieve complete and sustained BTK inhibition. Its optimized pharmacokinetic profile sets it apart from other BTK inhibitors, enabling effective suppression of malignant B-cell proliferation across multiple tissues. Brukinsa holds the distinction of being the BTK inhibitor with the broadest global regulatory approvals across multiple indications.-Fineline Info & Tech