Brukinsa approved in the U.S. for chronic lymphocytic leukemia.-BeiGene.

The U.S. approval is based on two global Phase III 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<0.0001), as assessed by an independent review committee (irc) in the first-line treatment setting. brukinsa achieved a superior overall response rate versus ibrutinib in the relapsed refractory (r r) treatment setting (orr 80.4% vs 72.9%, p="0.0264)," as assessed by an irc in the alpine trial.></0.0001),>

The overall safety profile of Brukinsa in the ALPINE and SEQUOIA trials was consistent with prior studies. In the pooled safety population of CLL patients who received Brukinsa across the clinical development program (N=1,550), the most common adverse reactions ( greater than 30%), were decreased neutrophil count (42%), upper respiratory tract infection (39%), decreased platelet count (34%), hemorrhage (30%), and musculoskeletal pain (30%).

The pre-defined final PFS analysis of the ALPINE study demonstrating superior efficacy and a favorable cardiac safety profile for Brukinsa versus Imbruvica in patients with R/R CLL, was presented in a late-breaking session at the 64th Annual American Society for Hematology (ASH) Meeting and published simultaneously in The New England Journal of Medicine.(previously cited) With a median follow-up of 29.6 months, Brukinsa demonstrated superior PFS compared with ibrutinib in patients with R/R CLL (HR: 0.65 [95% CI, 0.49-0.86] P=.0024, for Brukinsa both investigator and IRC). Additionally, Brukinsa demonstrated a favorable cardiac safety profile, with significantly lower rates of atrial fibrillation/flutter (5.2% vs 13.3%) and zero deaths due to cardiac disorders with Brukinsa vs. six with ibrutinib (0% vs 1.9%).