Swissmedic nod for Brukinsa for Waldenström's macroglobulinemia

China-based biotech BeiGene (HKEX: 06160) today announced that BeiGene’s BTK inhibitor Brukinsa (zanubrutinib) has received approval from Swissmedic for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior line of therapy, or for treatment-naïve patients who are not suited for standard chemo-immunotherapy. Brukinsa had previously been granted orphan drug status.

“The authorization of Brukinsa will bring a new option and an innovative medicine that has potential to offer deep and durable response for eligible patients with WM in Switzerland," said Prof Davide Rossi, deputy head of the Division of Hematology of the Oncology Institute of Southern Switzerland IOSI, noting that “Brukinsa is a next-generation BTK inhibitor which has also provided meaningful improvements in tolerability for some patients with WM compared to ibrutinib, as treatment discontinuation remains a concern.”

Reto Kessler, country manager, Switzerland at BeiGene, added: “This approval is a significant development for people living with WM in Switzerland and for BeiGene’s expansion in Europe. Our teams are committed to collaborating with the Federal Office of Public Health and healthcare professionals to ensure access to Brukinsa for patients in Switzerland.”