FDA Approves Tablet Formulation of Zanubrutinib for All Indications

A new tablet formulation of zanubrutinib (Brukinsa; BeOne) has been approved by the FDA for all 5 indications, making zanubrutinib the overall market share leader for Bruton tyrosine kinase (BTK) inhibitors, according to a press release from BeOne Medicines.¹

Zanubrutinib, a second-generation BTK inhibitor, is approved for the treatment of mantle cell lymphoma, Waldenström’s macroglobulinemia, chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, marginal zone lymphoma, and follicular lymphoma.² It is the leader in new CLL patient starts across all lines of therapy in the US, according to the press release.¹

The tablet formulation of zanubrutinib is now approved for all 5 indications across several hematological cancers, allowing patients to take 2 tablets rather than 4 capsules per day. | Image credit: wladimir1804 - AdobeStock_408414612

The new approval was based on 2 single-dose, open-label, randomized phase 1 crossover studies of healthy adults that intended to establish bioequivalence. Zanubrutinib tablets are 160 mg each, compared with 80-mg capsules. With the standard recommended dose of 320 mg daily, the new formulation allows patients to take 2 tablets rather than 4 capsules per day.

“[Zanubrutinib]’s leadership in the US underscores the trust physicians and patients have placed in its differentiated clinical profile,” Matt Shaulis, general manager of North America, BeOne, said in a statement.¹ “With this new tablet formulation, we are making treatment simpler and more convenient—an important step forward for patients facing certain B-cell cancers.”

References

1. U.S. FDA approves tablet formulation of BeOne’s Brukinsa for all approved indications. News release. BeOne Medicines. June 11, 2025. Accessed June 11, 2025. https://ir.beonemedicines.com/news/us-fda-approves-tablet-formulation-of-beones-brukinsar-for-all-approved-indications/644dc063-4114-48b8-9636-c60cb6cc6bd1

2. Brukinsa. Prescribing information. BeOne; 2025. Accessed June 11, 2025. https://d1e94vsyskgtht.cloudfront.net/brukinsa/pdfs/brukinsa-prescribing-information.pdf