Health Canada Approves Zanubrutinib for Patients with CLL

Zanubrutinib, a Bruton’s tyrosine kinase inhibitor (BTKi), has been approved by Health Canada for the treatment of adult patients with chronic lymphocytic leukemia (CLL).

The Health Canada approval of zanubrutinib for CLL is based on positive efficacy results and a favorable safety profile from two global phase III, randomized, open-label, multicenter clinical trials: the SEQUOIA trial, which compared zanubrutinib against bendamustine plus rituximab in patients with previously untreated CLL, and the ALPINE study, which compared zanubrutinib against ibrutinib in patients with relapsed or refractory CLL.

The BTKi was approved by the FDA in early 2023 for the treatment of CLL and small lymphocytic lymphoma.

Source: Business Wire, May, 2023