- The FDA has approved BeiGene Ltd’s (NASDAQ: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.
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