China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it has received approval from China’s National Medical Products Administration (NMPA) for four applications related to Brukinsa (zanubrutinib), the company’s Bruton’s tyrosine kinase inhibitor (BTKi). The approvals include two supplemental New Drug Applications (sNDAs) for the treatment of treatment-naïve adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and Waldenström’s macroglobulinemia (WM), along with two sNDAs that convert previous conditional approvals to regular approval.
Brukinsa’s Regulatory Milestones and Treatment Scope
Brukinsa received conditional approvals from the NMPA in June 2020 for the treatment of adults with CLL/SLL and mantle cell lymphoma (MCL) who have received at least one prior therapy. In June 2021, conditional approval was also granted for the treatment of adult patients with WM who have received at least one prior therapy. The NMPA has now converted these conditional approvals to regular approvals for R/R CLL/SLL and R/R WM, marking a significant regulatory milestone for BeiGene.
Implications for Patients and the Healthcare Sector
The conversion of conditional approvals to regular approvals for R/R CLL/SLL and R/R WM signifies a positive step forward in providing patients with more treatment options. This development is expected to have a substantial impact on the healthcare sector, offering a broader range of therapeutic choices for patients suffering from these conditions.-Fineline Info & Tech
