FDA Approves Tablet Form of BeOne's BRUKINSA for All Indications

SAN CARLOS, Calif.--BeOne Medicines Ltd., a prominent player in the oncology field, revealed that the U.S. Food and Drug Administration (FDA) has sanctioned a new tablet form of BRUKINSA® (zanubrutinib) for its five established uses. BRUKINSA has established itself as the leading choice for initiating chronic lymphocytic leukemia (CLL) treatments across various therapeutic lines in the U.S. Additionally, it has emerged as the overall leader in market share for BTK inhibitors.

The newly approved BRUKINSA tablets retain the effectiveness and safety profile of the original capsule formulation, which was confirmed in two single-dose, open-label, randomized Phase 1 crossover trials involving healthy participants. BRUKINSA stands out as the sole BTK inhibitor offering the convenience of flexible dosing, either once or twice a day, adaptable to patient requirements. It is also the only BTK inhibitor with dosing guidelines for patients with severe hepatic impairment.

Matt Shaulis, General Manager of North America at BeOne, remarked, “BRUKINSA's prominence in the U.S. highlights the confidence that physicians and patients place in its unique clinical attributes. The introduction of this tablet formulation simplifies treatment, which is a significant advancement for individuals dealing with specific B-cell cancers.”

The dosage recommendation for BRUKINSA continues to be 320 mg per day. The new tablets, each 160 mg, enable patients to consume two tablets daily as opposed to four 80 mg capsules. Furthermore, the tablets are smaller and have a film coating, facilitating easier ingestion. The transition from capsules to tablets is scheduled for October 2025.

The European Medicines Agency is currently assessing a Type II variation marketing authorization application for the tablet version of BRUKINSA, covering all approved indications, with a decision expected later this year.

BRUKINSA® (zanubrutinib) is an oral, small molecule inhibitor targeting Bruton’s tyrosine kinase (BTK). It is designed to provide complete and ongoing inhibition of the BTK protein by optimizing its bioavailability, half-life, and selectivity. BRUKINSA has shown enhanced pharmacokinetics compared to other available BTK inhibitors and has demonstrated the capability to hinder the multiplication of malignant B cells within various disease-relevant tissues.

Globally, BRUKINSA holds the most extensive label among BTK inhibitors and is uniquely capable of supporting either once or twice daily dosing. It has also proven superior to another BTK inhibitor in a Phase 3 trial. The worldwide BRUKINSA clinical development initiative has engaged approximately 7,100 patients across 30 countries and regions in over 35 studies. It is approved in over 75 markets for at least one indication, and more than 200,000 patients have received treatment globally.

BRUKINSA is indicated for treating adult patients with several conditions, including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and mantle cell lymphoma (MCL) after prior therapy. It is also approved for relapsed or refractory marginal zone lymphoma (MZL) following one anti-CD20-based regimen, and relapsed or refractory follicular lymphoma (FL) in combination with obinutuzumab after two or more systemic therapy lines.

The approval for MCL, MZL, and FL indications is accelerated based on response rate and durability, contingent on confirmatory trials verifying clinical benefit.

Patients undergoing BRUKINSA treatment may experience various adverse effects and require monitoring for serious conditions such as hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias, hepatotoxicity, and embryo-fetal toxicity. The most common side effects include decreased neutrophil count, platelet count, upper respiratory tract infections, hemorrhage, and musculoskeletal pain. Drug interactions with CYP3A inhibitors and inducers should be managed carefully.

BeOne Medicines is committed to developing innovative and accessible cancer treatments worldwide, fostering collaborations to advance a diverse pipeline of novel therapeutics. The company, headquartered in Switzerland, is focused on expanding access to essential medicines globally.