BeiGene Reports the US FDA Acceptance of sNDA for Brukinsa + Obinutuzumab for Adult Patients with R/R Follicular Lymphoma
Shots:
- The US FDA has accepted the sNDA for review of Brukinsa in combination with obinutuzumab in adult patients with r/r FL. The US FDA’s decision is expected in Q1’24
- The sNDA was based on the P-II study (ROSEWOOD) evaluating Brukinsa + obinutuzumab vs obinutuzumab alone in 217 patients. The combination therapy showed superior efficacy to obinutuzumab monotx. with an ORR (68.3% vs 45.8%) in the primary analysis at a median follow-up of 12.5mos., responses were durable with 18mos. landmark DoR of 69.3%
- The safety results were consistent with prior studies while the longer-term data incl. in the sNDA showed the efficacy benefit. The submissions for Brukinsa are under review by regulatory authorities in the EU & China for r/r FL
Ref: Businesswire | Image: BeiGene
Related News:- BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Approval for Chronic Lymphocytic Leukemia
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