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BeiGene's Brukinsa Scores FDA Approval For Marginal Zone Lymphoma

  • The FDA has granted accelerated approval to BeiGene Ltd’s (NASDAQ: 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.

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