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.
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