BeiGene's Brukinsa Scores FDA Approval For Marginal Zone Lymphoma

by Vandana Singh, Benzinga Editor

September 15, 2021 8:40 AM | 1 min read | Make a Comment

The FDA has granted accelerated approval to BeiGene Ltd's BGNE Brukinsa (zanubrutinib) for relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.
The accelerated approval is based on the overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The recommended dose of Brukinsa is either 160 mg twice daily or 320 mg once daily, taken orally with or without food.
Related content: Benzinga's Full FDA Calendar.
Price Action: BGNE stock is up 5.70% at $389.93 during the premarket session on the last check Wednesday.