Research & Development
BeiGene wins approval of BRUKINSA in the EU for treatment of Waldenström's Macroglobulinemia in adults
24 November 2021 -

Biotechnology company BeiGene (NASDAQ:BGNE)(HKEX:06160) reported on Tuesday the receipt of approval from the European Commission (EC) for BRUKINSA (zanubrutinib) for the treatment of adult patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy.

BRUKINSA's approval is applicable to all 27 European Union (EU) member states, plus Iceland and Norway. BRUKINSA is now approved in the United States, China, the European Union and nine other countries and regions, added the company.

The company stated the EC approval for BRUKINSA follows positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency based on the Phase 3 randomized, open-label, multicentre ASPEN clinical trial, which evaluated BRUKINSA versus ibrutinib in patients with relapsed or refractory (R/R)WM or treatment-naïve WM unsuitable for chemoimmunotherapy.

Although the primary endpoint of statistical superiority related to deep response was not met, BRUKINSA demonstrated clinical benefit with advantages in safety compared to ibrutinib under the company's ASPEN trial.

According to the company, BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton's tyrosine kinase (BTK) that is currently being evaluated globally in a broad clinical programme as a monotherapy and in combination with other therapies to treat various B-cell malignancies. It delivers complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life and selectivity.