NDA 218785, held by Beone Medicines USA. Zanubrutinib.
As of Nov 14, 2026, NDA 218785 (Brukinsa), held by Beone Medicines USA, was first approved by FDA on Jun 10, 2025, with 0 approved supplements and 0 published complete response letters.
BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Waldenström's macroglobulinemia (WM). Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. This indication is approved under accelerated approval based on overall response rate.
| Jun 10, 2025 | Original applicationNew dosage form · Standard review | Approved | |
| Jun 10, 2025 | Original applicationNew dosage form · Standard review | Approved |
| Brukinsa160MG · tablet;oral | Zanubrutinib | RxReference drug |
| Brukinsa80MG · capsule; oral | Zanubrutinib | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
