FDA Approves BeiGene's Brukinsa For Chronic Lymphocytic Leukemia

  • The FDA has approved BeiGene Ltd's BGNE Bruton's tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • "With four US approvals in just over three years and demonstrated superiority versus ibrutinib in the final progression-free survival (PFS) analysis of the ALPINE trial, we believe BRUKINSA is well-positioned to become the BTKi of choice across multiple indications," said Mehrdad Mobasher, Chief Medical Officer, Hematology at BeiGene.
  • Also Read: BeiGene's Brukinsa Shows Superior Progression-Free Survival Versus JNJ's Treatment.
  • The approval is based on two global Phase 3 clinical trials. 
  • With a median follow-up of 26.2 months in the SEQUOIA trial, Brukinsa demonstrated a significant PFS benefit versus bendamustine plus rituximab.
  • Brukinsa achieved a superior overall response rate versus ibrutinib in the relapsed/refractory (R/R) treatment setting (ORR 80.4% vs. 72.9%) in the ALPINE trial.
  • Price Action: BGNE shares closed at $274.50 on Thursday.
  • Photo Via Company
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