FDA approves BeOne's (ONC) BRUKINSA tablet

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of BRUKINSA® (zanubrutinib) for all five approved indications. BRUKINSA remains the leader in new chronic lymphocytic leukemia (CLL) 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.1

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.”

The recommended dose of BRUKINSA remains at 320 mg daily. The new BRUKINSA tablets are 160 mg each, allowing patients to take two tablets daily rather than four of the current 80 mg capsules. Additionally, BRUKINSA tablets are smaller than the capsules and have a film coating, making them easier to swallow. The BRUKINSA tablets will replace capsules starting in October 2025.

The European Medicines Agency is currently reviewing a Type II variation marketing authorization application (MAA) for the new tablet formulation of BRUKINSA in all currently approved indications, with approval expected later this year.

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