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# Brukinsa Priority NDA for Marginal Zone Lymphoma
- URL: https://www.fdaweb.com/brukinsa-priority-nda-for-marginal-zone-lymphoma/
- Published: 2021-05-21T12:00:00.000Z
- Updated: 2026-09-14T16:59:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149381

FDA has accepted for priority review a BeiGene supplemental NDA for Brukinsa (zanubrutinib) for treating adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. The agency set a 9/19 user fee action target date.

The submission is based on data from the Phase 2e results from the single-arm, open-label, multicenter, Phase 2 MAGNOLIA trial (NCT03846427) in patients with relapsed or refractory MZL. It also includes pooled safety data from 847 patients with B-cell malignancies treated with Brukinsa in seven clinical trials.

Brukinsa is currently FDA-approved for treating mantle cell lymphoma in adult patients who have received at least one prior therapy.