FDA Approves Simpler Way to Take Zanubrutinib (Brukinsa)

If you or a loved one is currently taking or considering starting the BTK inhibitor zanubrutinib (Brukinsa, BeOne Medicines), a new, easier-to-take option will be available starting in October 2025.

Zanubrutinib is currently approved for use in the treatment of:

• Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
• Relapsed or refractory follicular lymphoma (FL)
• Mantle cell lymphoma (MCL)
• Relapsed or refractory marginal zone lymphoma (MZL)
• Waldenström’s macroglobulinemia (WM) 

Zanubrutinib was previously taken as four 80 mg capsules. The U.S. Food and Drug Administration (FDA) has approved a new formulation that reduces this to two 160 mg tablets. These new tablets are also smaller and have an improved coating that makes them easier to swallow. The FDA confirmed that the tablets are just as effective as the previous capsule form.

Reducing the number of pills and making them easier to take may help improve treatment convenience and comfort for patients using this therapy.

“Brukinsa’s leadership in the U.S. underscores the trust physicians and patients have placed in its differentiated clinical profile. With this new tablet formulation, we are making treatment simpler and more convenient—an important step forward for patients facing certain B-cell cancers.” - Matt Shaulis, General Manager of North America, BeOne. 

Click the button below to learn more about how zanubrutinib works in CLL, its effectiveness, and ways to manage potential side effects.

CLL Therapy Guide: Zanubrutinib

Sources: 

• U.S. FDA Approves Tablet Formulation of BeOne’s BRUKINSA® for All Approved Indications
• Brukinsa