European Commission Approves Zanubrutinib Tablet Formulation for All Indications in B-Cell Malignancies

The European Commission has approved a tablet formulation of zanubrutinib (Brukinsa) for use in all previously authorized indications of the capsule formulation.1

This follows the FDA’s approval of the tablet formulation in June 2025.2

Zanubrutinib is approved in the European Union in the following indications:3

• as monotherapy for the treatment of adult patients with Waldenström macroglobulinemia who have received at least 1 prior therapy, or in first-line treatment for patients unsuitable for chemoimmunotherapy.
• as monotherapy for the treatment of adult patients with marginal zone lymphoma who have received at least 1 prior anti-CD20-based therapy.
• as monotherapy for the treatment of adult patients with chronic lymphocytic leukemia
• in combination with obinutuzumab (Gazyva) for the treatment of adult patients with refractory or relapsed follicular lymphoma who have received at least 2 prior systemic therapies

Notably, in the United States, zanubrutinib is also approved for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least 1 prior therapy; however, zanubrutinib does not hold any MCL indications in the European Union (EU).3,4

The recommended dose of the tablet formulation reflects that of the capsule formulation at 320 mg per day.1 Each tablet is 160 mg, allowing patients to take 2 tablets daily instead of 4 80-mg capsules.

"Developed to meet the real-world needs of patients, the new [zanubrutinib] tablet formulation aims to simplify treatment, reduce pill burden, and enhance ease of administration, reflecting our continuous focus on patient-centered innovation,” Giancarlo Benelli, senior vice president and head of Europe at BeOne Medicines, stated in a news release. “With more than 200,000 patients treated globally and the broadest label of any BTK inhibitor in Europe, zanubrutinib’s differentiated clinical profile continues to make an impact for people facing certain B-cell cancers."

Safety Overview

Compiled safety data in the zanubrutinib European Union prescribing information show that most common occurring adverse effects reported in at least 20% of patients treated with zanubrutinib monotherapy (n = 1550) included upper respiratory tract infection(36%), bruising (32%), hemorrhage/hematoma(30%), neutropenia(30%), musculoskeletal pain(27%), rash(25%), pneumonia(24%), diarrhea (21%), and cough(21%).3

The most common grade 3 or higher AEs that occurred in at least 3% of patients comprised neutropenia (21%), pneumonia (14%), hypertension (8%), thrombocytopenia (6%), anemia (6%), and hemorrhage/hematoma (4%). AEs led to treatment discontinuation of zanubrutinib monotherapy in 4.8% of patients, with the most common being pneumonia(2.6%). AEs led to dose reductions in 5.0% of patients.

In the phase 2 ROSEWOOD trial (NCT03332017), among patients with relapsed/refractory follicular lymphoma treated with zanubrutinib in combination with obinutuzumab (n = 143), the most common AEs reported in at least 20% of patients included thrombocytopenia(37%), neutropenia(31%), and fatigue(27%). Grade 3 or higher AEs reported in more than 3% of patients included neutropenia§ (25%), thrombocytopenia(16%), pneumonia(15%), and anemia (5%). AEs led to treatment discontinuation in 4.9% of patients, with the most common being pneumonia (4.2%). AEs led to dose reduction in 7.0% of patients.

References

1. The European Commission has approved a tablet formulation of BeOne Medicines’ Brukinsa for use across all of its previously authorized indications. News release. BeOne Medicines. August 21, 2025. Accessed August 21, 2025. https://ir.beonemedicines.com/news/european-commission-approves-tablet-formulation-of-beone-medicines-brukinsar-for-all-approved-indications/60a73cd1-3e95-46b4-b377-578f401440b9
2. U.S. FDA approves tablet formulation of BeOne’s Brukinsa for all approved indications. News release. BeOne. June 11, 2025. Accessed August 21, 2025. https://www.businesswire.com/news/home/20250611860939/en/U.S.-FDA-Approves-Tablet-Formulation-of-BeOnes-BRUKINSA-for-All-Approved-Indications
3. Brukinsa. European Medicines Agency. Accessed August 21, 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/brukinsa
4. Brukinsa. Prescribing information. BeOne. Updated June 2025. Accessed August 21, 2025. https://beonemedicines.us/PDF/BRUKINSAUSPI.pdf