On June 25, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of a new film-coated tablet formulation of BRUKINSA (zanubrutinib) for all approved indications (Press release, BeOne Medicines, JUN 25, 2025, View Source [SID1234654125]). The CHMP positive opinion will now be reviewed by the European Commission, which will grant the marketing authorization for the tablet formulation in the European Union and in the European Economic Area countries Norway and Iceland.
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"The CHMP’s positive opinion of our new tablet formulation of BRUKINSA is an important step toward bringing this thoughtful, patient-centered innovation to people facing certain B-cell cancers across Europe," said Giancarlo Benelli, Senior Vice President and Head of Europe, BeOne. "We look forward to a potential approval later this year and remain committed to delivering our impactful medicines to more patients in the region."
The BRUKINSA tablets have been shown to be bioequivalent to the BRUKINSA capsules based on the results of two single-dose, open-label, randomized Phase 1 crossover studies in healthy subjects. The recommended dose of BRUKINSA remains – 320 mg daily. The BRUKINSA tablets are 160 mg each, allowing patients to halve their daily pill intake and take two tablets daily. The new tablet formulation maintains BRUKINSA’s dosing flexibility by providing patients and prescribers with the option of once- or twice-daily dosing and is designed to simplify management of dose reductions as per label recommendation. Additionally, the BRUKINSA tablets are smaller than the capsules and have a film coat, which makes them easier to swallow.
BeOne Medicines will begin to convert BRUKINSA from capsules to tablets in regions outside China in 2025 as part of our commitment to sustainable business practices, including reducing our impact on the environment. This adjustment will decrease the bottle size by ~70% while also enabling the shipment of this medication with reduced temperature controls, which we expect to reduce energy needs, greenhouse gas emissions, and global transport costs.
Today’s announcement follows the U.S. Food and Drug Administration (FDA) approval of the new tablet formulation of BRUKINSA for all five approved indications earlier this month. In the U.S., BRUKINSA is the leader in new patient starts for chronic lymphocytic leukemia (CLL) across all lines of therapy, and for the first time, has become the overall BTK inhibitor market share leader.1
Important Safety Information
The current European Summary of Product Characteristics (SmPC) of BRUKINSA is available from the website of the European Medicines Agency.
This information is intended for a global audience. Product indications vary by region.