Policy & Regulation
Brukinsa Approved in the US for Chronic Lymphocytic Leukemia
25 January 2023 - - The US Food and Drug Administration has approved China-based biotechnology company BeiGene's (NASDAQ: BGNE) (HKEX: 06160) (SSE: 688235) Bruton's tyrosine kinase inhibitor Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, the company said.

The US approval is based on two global Phase 3 clinical trials demonstrating superior efficacy and a favorable safety profile for Brukinsa in CLL:

With a median follow-up of 26.2 months in the SEQUOIA trial, Brukinsa demonstrated a significant PFS benefit versus bendamustine plus rituximab, (HR 0.42, [95% CI: 0.28, 0.63], P