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# BeiGene sNDA for Brukinsa in Lymphoma
- URL: https://www.fdaweb.com/beigene-snda-for-brukinsa-in-lymphoma/
- Published: 2023-07-12T12:00:00.000Z
- Updated: 2026-09-14T18:43:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154863

FDA has accepted a BeiGene supplemental NDA for Brukinsa (zanubrutinib) in combination with obinutuzumab for treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after at least two prior lines of therapy. The agency has set a user fee review action target date in the first quarter of 2024.

The submission is based on data from the Phase 2 ROSEWOOD study (NCT03332017) that included 217 patients with pre-treated R/R non-Hodgkin FL (145 receiving Brukinsa plus obinutuzumab and 72 patients receiving obinutuzumab monotherapy). “In the primary ROSEWOOD analysis at a median follow-up of 12.5 months, Brukinsa plus obinutuzumab demonstrated superior efficacy to obinutuzumab monotherapy with a 68.3% overall response rate (ORR) versus 45.8% respectively (p = 0.0017),” the company says.

Longer-term data (median follow-up of 20 months) contained in the sNDA demonstrated an ORR for the combination therapy of 69.0% versus 45.8% for obinutuzumab monotherapy, the company says. Additionally, the combination therapy reduced the risk of disease progression or death by 50% compared with obinutuzumab alone, it adds.

Regarding safety, BeiGene says that results from the ROSEWOOD study were consistent with previous studies of both medicines. The most common adverse events reported in the primary analysis for the combination arm compared with the obinutuzumab alone arm were diarrhea (18.2% vs 16.9%), fatigue (15.4% vs 14.1%), and pyrexia (13.3% vs 19.7%).

Brukinsa is a kinase inhibitor indicated for treating adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, Waldenström’s macroglobulinemia, mantle cell lymphoma, and relapsed or refractory marginal zone lymphoma.