BRIEF—Canadian approval for Brukinsa in chronic lymphocytic leukemia

China-headquartered biotech BeiGene today revealed that its Brukinsa (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).

“Brukinsa now has four approved indications in Canada, demonstrating our commitment to bring this innovative BTKi treatment option to more patients across the world,” said Dr Mehrdad Mobasher, chief medical officer, hematology, at BeiGene.

The Health Canada approval of Brukinsa for CLL is based on positive efficacy results and a favorable safety profile from two global Phase III, randomized, open-label, multicenter clinical trials: SEQUOIA (NCT03336333), comparing zanubrutinib against bendamustine plus rituximab (BR) in patients with previously untreated CLL, and ALPINE (NCT03734016), comparing zanubrutinib against ibrutinib in patients with relapsed or refractory (R/R) CLL.