BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biotech company based in China, has announced its latest indication approval in the United States for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The US Food and Drug Administration (FDA) has granted approval for Brukinsa in combination with the anti-CD20 monoclonal antibody obinutuzumab as a third-line or later treatment for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
The FDA’s accelerated approval for FL marks Brukinsa’s fifth indication in the US, based on the overall response rate (ORR) data from the Phase II ROSEWOOD trial (NCT03332017). In the trial involving 217 patients with R/R FL, the combination of Brukinsa and obinutuzumab achieved an ORR of 69%, significantly higher than the 46% observed with obinutuzumab alone (P=0.0012), with a median follow-up of approximately 20 months. Additionally, Brukinsa demonstrated durable treatment benefits, with an 18-month landmark duration of response (DOR) at 69%.
Other approved US indications for Brukinsa include adult patients with Waldenström’s macroglobulinemia or mantle cell lymphoma who have received at least one prior therapy, R/R marginal zone lymphoma patients who have received at least one anti-CD20-based regimen, and chronic lymphocytic leukemia or small lymphocytic lymphoma. The drug’s global sales reached USD 1.3 billion in 2023, showing a 129% year-on-year growth, and it is expected to continue expanding its sales in 2024.- Flcube.com
