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Highlights

  • BeOne Medicines receives FDA approval for tablet formulation of BRUKINSA for all approved uses.
  • The BRUKINSA tablet 160 mg tablets reduce daily pill count and are expected to replace capsules by October 2025.
  • The EMA is expected to issue a decision on the tablet version by late 2025.

BeOne Medicines Ltd. (NASDAQ:ONC) has announced that the U.S. Food and Drug Administration (FDA) has approved a tablet version of its BTK inhibitor BRUKINSA® (zanubrutinib). The tablet formulation is approved for use across all five existing indications in the United States.

The approval is based on findings from two open-label, randomized Phase 1 crossover studies involving healthy adults. These studies demonstrated that the tablet and capsule forms of BRUKINSA are bioequivalent, meaning they offer similar levels of efficacy and safety. As a result, the new formulation can serve as a direct alternative to the previously approved capsule version.

The BRUKINSA tablet is 160 mg, with the recommended daily dose remaining at 320 mg. Patients will now be able to take two tablets per day instead of four 80 mg capsules. The tablets are film-coated and smaller in size, intended to improve ease of swallowing and reduce the daily pill burden. BeOne has indicated that the tablet form is expected to fully replace the capsule formulation beginning in October 2025.

BRUKINSA is used in the treatment of various B-cell malignancies, including chronic lymphocytic leukemia (CLL). It is the only currently approved BTK inhibitor that allows for both once- or twice-daily dosing and includes specific recommendations for use in patients with severe hepatic impairment. These attributes will carry over to the tablet version.

BeOne reports that BRUKINSA has become the leading BTK inhibitor by new patient starts in the U.S. CLL market and now holds the largest overall market share in the BTK class. The company attributes the drug’s adoption to its clinical profile, which includes flexibility in dosing and its established safety and efficacy.

A regulatory submission for the tablet formulation is currently under review by the European Medicines Agency (EMA). The application, submitted as a Type II variation to the existing marketing authorisation, seeks approval for the tablet form across all previously approved indications in Europe. A final decision is expected later in 2025.

BRUKINSA works by targeting Bruton’s tyrosine kinase (BTK), a protein critical to the survival and proliferation of malignant B cells. It has been studied in a range of B-cell related cancers and has received approval in over 75 markets globally. According to the company, over 200,000 patients have received BRUKINSA treatment to date.

BeOne’s global clinical development program for BRUKINSA includes over 7,000 patients across more than 35 trials in 30 countries. The therapy has been evaluated in multiple lines of treatment and in comparison, with other agents in its class.

About BeOne Medicines

BeOne Medicines is a biopharmaceutical company focused on oncology. Listed on exchanges in the U.S., Hong Kong, and China, the company develops targeted therapies aimed at improving outcomes for patients with hematological malignancies and solid tumors. In addition to BRUKINSA, its research and development pipeline includes a range of oncology candidates in various stages of clinical testing.