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