U.S. FDA Grants BRUKINSA® (Zanubrutinib) Accelerated Approval in Relapsed or Refractory Marginal Zone Lymphoma
BeiGene, Ltd. - American Depositary Shares (BGNE)
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Source: Business Wire
This marks the third FDA approval for BRUKINSA and first approval in marginal zone lymphomaTwenty percent of patients achieved complete remission with single-agent BRUKINSABRUKINSA was generally well-tolerated, consistent with its known safety profile CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that BRUKINSA® (zanubrutinib) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210915005310/en/(Photo: Business Wire)This accelerated approval is based on overall response rate (ORR). Continued approval for this indication may be continge
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- Shareholders in BeiGene (NASDAQ:BGNE) have lost 54%, as stock drops 8.5% this past week [Yahoo! Finance]Yahoo! Finance
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