Weekly Digest - 06-12 May 2023
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - 06-12 May 2023
May 06, 2023: Brukinsa (Zanubrutinib) / Chronic lymphocytic leukemia (CLL) /Small lymphocytic lymphoma (SLL) / Waldenstrom’s macroglobulinemia (WM) / BeiGene: Received NMPA approval for multiple indications
- This approval for CLL/SLL was supported by the data from the Phase 3 SEQUOIA trial and the approval for patients with Waldenström macroglobulinemia was based on findings from the Phase 3 ASPEN trial
With these approvals, Brukinsa has become the only approved new-generation BTKi in China for the 1L treatment of CLL/SLL and WM patients
Brukinsa previously received conditional approvals from NMPA for the treatment of R/R CLL/SLL and R/R MCL (Jun 2020) as well as for the treatment of R/R WM (Jun 2021)
NMPA converted these conditional approvals to regular approvals in Apr 2023
