BeiGene announced that the Center for Drug Evaluation of the China National Medical Products Administration has accepted a supplemental new drug application for BeiGene's BTK inhibitor BRUKINSA as a treatment for adult patients with Waldenström's macroglobulinemia. The sNDA is supported by clinical results from the randomized, open-label, multicenter Phase 3 ASPEN trial comparing BRUKINSA to ibrutinib in patients with relapsed or refractory or treatment-naïve WM. As assessed by an independent review committee based on the modified Sixth International Workshop on Waldenström's Macroglobulinemia response criteria, the combined rate of complete response and very good partial response in the overall intention-to-treat population was 28% with BRUKINSA, compared to 19% with ibrutinib.

While this difference was not statistically significant, BRUKINSA did achieve numerically higher VGPR rates and trends towards increased response quality. In the ASPEN trial, BRUKINSA demonstrated a more favorable safety profile compared to ibrutinib with lower frequency of certain adverse events, including atrial fibrillation or flutter (2% vs. 15%) and major hemorrhage (6% vs.

9%). Of the 101 patients with WM treated with BRUKINSA, 4% of patients discontinued due to adverse events, and adverse events leading to dose reduction occurred in 14% of patients.