Zanubrutinib Receives Breakthrough Therapy Designation for CLL in China

The Center for Drug Evaluation of the China National Medical Products Administration has accepted a supplemental new drug application (sNDA) for the Bruton tyrosine kinase (BTK) inhibitor zanubrutinib for the treatment of adults with treatment-naïve chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In addition, the agency has granted breakthrough therapy designation to zanubrutinib for this indication.

Supporting the sNDA are data from the phase III SEQUOIA trial (NCT03336333) comparing zanubrutinib with bendamustine plus rituximab in patients with treatment-naïve CLL. For patients treated with zanubrutinib, the 24-month progression-free survival (PFS) rate was 85.5%, compared with 69.5% for those treated with bendamustine in combination with rituximab.

Zanubrutinib was previously approved for relapsed/refractory CLL/SLL in China in June 2020.

Source: BeiGene press release, Jan. 28, 2022.