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# BeiGene’s Brukinsa OK’d for Marginal Zone Lymphoma
- URL: https://www.fdaweb.com/beigenes-brukinsa-okd-for-marginal-zone-lymphoma/
- Published: 2021-09-15T12:00:00.000Z
- Updated: 2026-09-14T17:14:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150149

FDA has granted accelerated approval for BeiGene’s Brukinsa (zanubrutinib) for treating adult patients with relapsed or refractory marginal zone lymphoma who have received at least one anti-CD20-based regimen. Approval is based on efficacy data from two single-arm clinical trials, with overall response rate (ORR) as the primary endpoint, according to the company.

In the Phase 2 MAGNOLIA trial (NCT03846427), 66 patients were evaluated. Based on assessment using CT scanning, the ORR was 56% with a complete response (CR) rate of 20%. In the Phase 1/2 trial BGB-3111-AU-003 (NCT02343120), a total of 20 patients were assessed. Based on an assessment using CT scanning, the ORR was 80% with a CR rate of 20%.

BeiGene says Brukinsa is a small molecule inhibitor of Bruton’s tyrosine kinase that is currently being evaluated globally for treating B-cell malignancies, according to the company. It was approved 11/2019 for mantle cell lymphoma in adult patients who have received at least one prior therapy.