China-based BeiGene Ltd (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), has received the latest indication approval in Canada for the treatment of chronic lymphocytic leukemia (CLL). This approval marks the fourth total approved Canadian indication for Brukinsa, following earlier approvals for marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and Waldenström’s macroglobulinemia (WM).
Supporting Data and Clinical Trials
The latest Canadian approval is supported by data from two global Phase III trials: SEQUOIA (NCT03336333) and ALPINE (NCT03734016). The SEQUOIA trial compared zanubrutinib against bendamustine plus rituximab (BR) in patients with previously untreated CLL, while the ALPINE trial compared zanubrutinib against ibrutinib in patients with relapsed or refractory (R/R) CLL. These trials provide a robust evidence base for the efficacy and safety of Brukinsa in treating CLL.
Impact on Canadian CLL Patients
The approval of Brukinsa for CLL in Canada means that the drug will be made available to the approximately 2,200 CLL sufferers diagnosed each year in the country. This expansion of treatment options is expected to have a significant impact on the Canadian CLL patient population, offering a new therapeutic choice for those affected by the disease.-Fineline Info & Tech
