Benzinga | Nov 23, 2021 05:07PM EST

BeiGene Announces Approval of BRUKINSA In European Union For Treatment Of Adults With Waldenstrm's Macroglobulinemia

BeiGene (NASDAQ:BGNE, HKEX: 06160))))) announced today that the European Commission (EC) approved BRUKINSA(r) (zanubrutinib) for the treatment of adult patients with Waldenstr?m's macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy. The approval is applicable to all 27 European Union (EU) member states, plus Iceland and Norway. BeiGene is working to make this new treatment option available to WM patients in the EU as quickly as possible.

"BTK inhibition is an established mode of treatment for patients with WM, and the approval of BRUKINSA provides an important new option for patients with WM that may offer improved outcomes," said Prof. Christian Buske, Medical Director at the University Hospital Ulm, Germany, and a trial investigator of the ASPEN study. "Patients and their physicians in the EU will soon have access to an innovative medicine that has potential to offer deep and durable responses and improved tolerability, as seen in the ASPEN trial."

The EC approval for BRUKINSA follows a positive opinion granted in September by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), based on the results of the ASPEN trial. Although the primary endpoint of statistical superiority related to deep response, very good partial response (VGPR) or better, was not met, BRUKINSA demonstrated clinical benefit with advantages in safety compared to ibrutinib.1 Read more about the positive CHMP opinion and ASPEN trial results here.

"With BRUKINSA now approved in the EU, we continue to execute on our commitment of making this potentially best-in-class BTK inhibitor available for more patients around the world who may benefit," said Jane Huang, M.D., Chief Medical Officer, Haematology at BeiGene. "BRUKINSA was designed to maximize BTK occupancy and minimize off-target effects and has demonstrated efficacy and advantages in safety and tolerability over ibrutinib in the ASPEN trial. We believe BRUKINSA will become the preferred treatment option among patients with WM and their physicians."

"We have built a strong team in Europe that is committed to creating access to BRUKINSA for patients living with WM," said Gerwin Winter, Senior Vice President, Head of Commercial, Europe at BeiGene. "This approval by the European Commission is a significant milestone for BeiGene's expansion in the region, representing another step towards BeiGene's goal of increasing access to innovative oncology medicines globally."