BeOne Medicines, a global oncology company, announces that the European Commission has approved a new film-coated tablet formulation of BRUKINSA (zanubrutinib) for all approved indications.
"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-centred 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.
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 optimising 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.