NMPA (China) gives conditional approval for Brukinsa to treat adult patients with Waldenström’s macroglobulinemia .- BeiGene Ltd.

The supplemental new drug application was previously granted priority review by the Center for Drug Evaluation (CDE) of the NMPA in October 2020.

The conditional approval granted by the NMPA was based on findings from a single-arm pivotal Phase II trial (NCT03332173) in China evaluating the safety and efficacy of Brukinsa in patients with WM who have received at least one prior therapy. With a median study follow-up time of 14.9 months, the primary endpoint of major response rate (MRR) as assessed by independent review committee (IRC) was 72.1% (95% CI: 56.3, 84.7); MRR is defined as the combined rate of complete responses, very good partial responses, and partial responses. The adverse reaction profile was generally consistent with previous findings.