BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has achieved its latest global approval for the Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The European Commission has approved Brukinsa in combination with obinutuzumab (Roche’s CD20-targeted Gazyva) as a third-line treatment for relapsed or refractory (R/R) follicular lymphoma (FL). This marks Brukinsa’s fourth approval in the EU, establishing it as the leading BTK inhibitor in the region in terms of the number of indication approvals.
Approval Based on Global Phase II ROSEWOOD Trial
The approval was supported by the results of the global Phase II ROSEWOOD trial (NCT03332017), which demonstrated the superiority of Brukinsa in combination with Gazyva over Gazyva alone in treating r/r FL patients. In the trial involving 217 patients with R/R FL, the overall response rate for Brukinsa + Gazyva was 69.0% compared to 45.8% for Gazyva alone. The duration of response for Brukinsa was 69.3%, and the median progression-free survival (PFS) was significantly longer at 28.0 months for the combination therapy versus 10.4 months for Gazyva monotherapy.
Brukinsa’s Other EU Approvals
Brukinsa has received other EU approvals for the treatment of adult patients with chronic lymphocytic leukemia, for adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy, and for adult patients with Waldenström’s macroglobulinemia who have received at least one prior therapy, or as a first-line treatment for patients unsuitable for chemo-immunotherapy.- Flcube.com
