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BeiGene Reports the US FDA Acceptance of sNDA for Brukinsa + Obinutuzumab for Adult Patients with R/R Follicular Lymphoma

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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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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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