FDA green light for Brukinsa for Waldenström's macroglobulinemia

Shares of Chinese biotech firm BeiGene (HKEX: 06160) closed up nearly 5% at HK$198.10 today, after it announced that its Brukinsa (zanubrutinib) has received approval from the US Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).

“We are delighted by today’s FDA approval for Brukinsa in its second indication, offering a new treatment option with demonstrated efficacy and safety benefits for patients with Waldenström’s macroglobulinemia. As shown in the ASPEN trial, Brukinsa can improve treatment outcomes for these patients and potentially make a positive impact on their lives,” commented Dr Jane Huang, chief medical officer, hematology, at BeiGene.

Dr Huang continued: “With 11 regulatory approvals in under two years, including two in the US, Brukinsa is demonstrating its growing utility as a treatment option for B-cell malignancies and expanding its footprint to potentially benefit more patients worldwide. We will continue to evaluate Brukinsa in its broad global clinical program and look forward to additional clinical evidence to establish its position as a potentially best-in-class medicine.”