On August 21, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the European Commission has approved a new film-coated tablet formulation of BRUKINSA (zanubrutinib) for all approved indications (Press release, BeOne Medicines, AUG 21, 2025, View Source [SID1234655427]).
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"Developed to meet the real-world needs of patients, the new BRUKINSA tablet formulation aims to simplify treatment, reduce pill burden, and enhance ease of administration, reflecting our continuous focus on patient-centered innovation," said Giancarlo Benelli, Senior Vice President and Head of Europe, BeOne. "With more than 200,000 patients treated globally and the broadest label of any BTK inhibitor in Europe, BRUKINSA’s differentiated clinical profile continues to make an impact for people facing certain B-cell cancers."
The recommended dose of BRUKINSA continues to be 320 mg daily. The BRUKINSA tablets are 160 mg each, allowing patients to halve their daily pill intake from four pills to two. Additionally, they are smaller than the capsules and have film coatings, which make them easier to swallow.
Important Safety Information
The current European Summary of Product Characteristics (SmPC) of BRUKINSA is available from the website of the European Medicines Agency.
The information provided in this press release is intended for a global audience.
About BRUKINSA (zanubrutinib)
BRUKINSA is an orally available, small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.
BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. Additionally, BRUKINSA is the only BTK inhibitor to demonstrate PFS superiority to a first-generation BTK inhibitor in a Phase 3 study.
The global BRUKINSA clinical development program includes approximately 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved for at least one indication in more than 75 markets, and more than 200,000 patients have been treated globally.