BeiGene announces acceptance of sDNA in China for Brukinsa in chronic lymphocytic leukemia or small lymphocytic lymphoma .

“This is Brukinsa ’s first filing in treatment-naïve CLL supported by the positive global Phase III SEQUOIA trial, a remarkable step forward in its global registration program. As presented at ASH, Brukinsa significantly prolonged progression-free survival and was generally well-tolerated in these patients, with demonstrated superiority over chemoimmunotherapy in the SEQUOIA trial,” commented Jane Huang, M.D., Chief Medical Officer of Hematology at BeiGene. “Together with the filing in Waldenström’s macroglobulinemia, we are hoping to expand the clinical use of this potential best-in-class BTK inhibitor from relapsed or refractory setting to frontline care for the blood cancer community in China.”

The sNDA is supported by clinical results from the randomized, multicenter, global Phase III SEQUOIA trial (NCT03336333) comparing Brukinsa to bendamustine in combination with rituximab (B+R) in patients with treatment-naïve CLL. As assessed by an independent review committee (IRC), Brukinsa demonstrated superiority in progression-free survival (PFS) over B+R. With a median follow-up of 26.15 months, the 24-month PFS was 85.5% (95% CI: 80.1, 89.6) with Brukinsa compared to 69.5% (95% CI: 62.4, 75.5) with B+R, and the hazard ratio (HR) was 0.42 (95% CI: 0.27, 0.63), p<0.0001. brukinsa was generally well tolerated with a safety profile consistent with its broad clinical program, including a low rate of atrial fibrillation.></0.0001.>