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# Accelerated Approval for Brukinsa for Some Lymphomas
- URL: https://www.fdaweb.com/accelerated-approval-for-brukinsa-for-some-lymphomas/
- Published: 2024-03-07T12:00:00.000Z
- Updated: 2026-09-14T14:24:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156503

FDA has granted accelerated approval to BeiGene USA’s Brukinsa (zanubrutinib) with obintuzumab (Genentech’s Gazyva) for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. An agency [notice](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-relapsed-or-refractory-follicular-lymphoma?ref=fdaweb.com) says the regimen was evaluated in a trial of 217 patients. Efficacy was based on the overall response rate and duration of response, it says.

The most common adverse reactions included decreased neutrophil counts and platelet counts, upper respiratory tract infection, hemorrhage, and musculoskeletal pain. Serious adverse reactions occurred in 35% of patients who received the Brukinsa plus Gazyva regimen, the notice says.

FDA says its review used the Assessment Aid, a voluntary submission from the applicant to facilitate the agency assessment. The application received fast-track and orphan drug designations.