BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company based in China, has received conditional approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The approval is for the use of Brukinsa in combination with the CD20-targeted obinutuzumab for the treatment of recurrent or refractory (R/R) follicular lymphoma (FL) in patients who have received at least two prior systemic treatments.
The approval is supported by the results of the ROSEWOOD study, a global, randomized, open, multi-center Phase II trial that evaluated the efficacy and safety of the combination of zanubrutinib and obinutuzumab compared to obinutuzumab alone in 217 patients with the specified indication. The study outcomes confirmed the efficacy and safety of the combination regimen.
Brukinsa previously received conditional approvals from the NMPA in June 2020 for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL) who have received at least one prior therapy. In June 2021, it received conditional approval for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy. These conditional approvals were converted to regular approvals for R/R CLL/SLL and R/R WM in April 2023. In May 2023, Brukinsa was granted an additional indication for use in newly diagnosed adult patients with CLL/SLL and WM.- Fineline.com
