NDA 213217, held by Beone Medicines USA. Zanubrutinib.
As of Nov 14, 2026, NDA 213217 (Brukinsa), held by Beone Medicines USA, was first approved by FDA on Nov 14, 2019, with 8 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.
| Mar 7, 2024 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Dec 21, 2023 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Jan 19, 2023 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2021 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Aug 31, 2021 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Nov 14, 2019 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Brukinsa80MG · capsule;oral | Zanubrutinib | DiscontinuedReference drug |
| Jan 24, 2025 | Supplement 15Labeling · Standard review | Approved | |
| Jun 4, 2024 | Supplement 14Labeling | Approved | |
| Mar 7, 2024 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Dec 21, 2023 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Apr 21, 2023 | Supplement 10Labeling · Standard review | Approved | |
| Jan 19, 2023 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2021 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Aug 31, 2021 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Nov 14, 2019 | Original applicationNew molecular entity · Priority review | Approved |
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
