FDA Approves Zanubrutinib Tablets in Multiple Hematologic Indications

Zanubrutinib tablets were found to have the same efficacy and safety as capsules based on 2 single-dose, open-label randomized phase 1 studies.

The FDA has approved a tablet formulation of zanubrutinib (Brukinsa) across 5 hematologic indications, including chronic lymphocytic leukemia or small lymphocytic lymphoma; Waldenström macroglobulinemia; pretreated mantle cell lymphoma; relapsed/refractory marginal zone lymphoma following at least 1 CD20-based regimen; and with obinutuzumab (Gazyva) in relapsed/refractory follicular lymphoma following at least 2 lines of systemic therapy, according to a news release from the drug’s developer, BeOne Medicines, Ltd.

The FDA decision is based on results from 2 phase 1 crossover studies, in which zanubrutinib tablets showed comparable efficacy and safety outcomes to capsules, offering a simplified dosing experience and easier administration. The trials were conducted in healthy adults to establish bioequivalence between the 2 treatment modalities.

The recommended zanubrutinib dose is 320 mg daily, and the new tablets contain 160 mg each vs 80 mg each with the capsules, enabling patients to take only 2 tablets vs the current 4 capsules. Additionally, the tablets have a reduced size and a film coating, enhancing the ease of swallowing for patients. The tablets are set to replace the capsules in October 2025.

“[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 the news release. “With this new tablet formulation, we are making treatment simpler and more convenient—an important step forward for patients [with] certain B-cell cancers.”

Additionally, the European Medicines Agency is reviewing a Type II variation marketing authorization application for the zanubrutinib tablet formulation in all 5 indications, with an expected action date later this year.

Reference

U.S. FDA approves tablet formulation of BeOne’s BRUKINSA® for all approved indications. News release. BeOne Medicines, Ltd. June 11, 2025. Accessed June 11, 2025. https://tinyurl.com/3a42b49a